Medical Device Manufacturer · US , White Bear Lake , MN

Nonin Medical, Inc.

50 submissions · 50 cleared · Since 1986
50
Total
50
Cleared
0
Denied

Nonin Medical, Inc. — FDA 510(k) Submissions

Nonin Medical, Inc. has submitted 50 FDA 510(k) premarket notifications since 1986, of which 50 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Oximeter, Oximeter, Tissue Saturation, System, Measurement, Blood-pressure, Non-invasive, Pulse Oximeter For Over-the-counter Use, Analyzer, Gas, Carbon-dioxide, Gaseous-phase . Use the specialty filter in the sidebar to narrow results.

50 devices
1–25 of 50
Nonin OTC Pulse Oximeter Model 3250
K211498 · OLK Pulse Oximeter For... · Anesthesiology
Nov 2024 1279d
H500 Multi-Sensing Oximetry System
K192900 · DQA Oximeter · Anesthesiology
Jun 2020 258d
Pulse Oximeter
K191403 · DQA Oximeter · Anesthesiology
Dec 2019 210d
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
K190560 · MUD Oximeter, Tissue Saturation · General & Plastic Surgery
May 2019 58d
Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
K172625 · DQA Oximeter · Anesthesiology
May 2018 252d
Model X-100C CO-Met? Oximetry System
K160231 · DQA Oximeter · Anesthesiology
Dec 2016 326d
Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso
K160865 · DQA Oximeter · Anesthesiology
Aug 2016 128d
SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)
K151305 · MUD Oximeter, Tissue Saturation · Cardiovascular
Aug 2015 101d
PULSE OXIMETER
K140785 · DQA Oximeter · Anesthesiology
Jul 2014 98d
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
K132402 · DQA Oximeter · Anesthesiology
Feb 2014 204d
PULSE OXIMETER
K131021 · DQA Oximeter · Anesthesiology
Sep 2013 152d
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
K113215 · MUD Oximeter, Tissue Saturation · Cardiovascular
May 2012 195d
PULSE OXIMETER
K112843 · DQA Oximeter · Anesthesiology
Apr 2012 203d
PULSE OXIMETER
K102350 · DQA Oximeter · Anesthesiology
Dec 2010 125d
REGIONAL OXIMETER
K102715 · MUD Oximeter, Tissue Saturation · Cardiovascular
Dec 2010 88d
SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
K093853 · DQA Oximeter · Anesthesiology
Jun 2010 170d
SINGLE-PATIENT USE DISPOSABLE SENSOR
K093306 · DQA Oximeter · Anesthesiology
Mar 2010 133d
REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES
K092101 · DQA Oximeter · Anesthesiology
Oct 2009 99d
EVISION DATA MANAGEMENT SOFTWARE
K092678 · DQA Oximeter · Anesthesiology
Oct 2009 30d
REGIONAL OXIMETER SYSTEM, MODEL 7600
K090807 · MUD Oximeter, Tissue Saturation · Cardiovascular
Jun 2009 97d
FINGER PULSE OXIMETER, MODEL 9560
K081285 · DQA Oximeter · Anesthesiology
Jun 2008 30d
NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER
K080255 · DQA Oximeter · Anesthesiology
May 2008 113d
DIGITAL PULSE OXIMETER, MODEL 7500FO
K071415 · DQA Oximeter · Anesthesiology
Aug 2007 79d
DIGITAL PULSE OXIMETER, MODEL 7500
K071285 · DQA Oximeter · Anesthesiology
Jul 2007 66d
LIFESENSE, MODEL LS1-9R
K063752 · DQA Oximeter · Anesthesiology
May 2007 136d
Filters