Medical Device Manufacturer · US , Mchenry , IL

Salter Labs

48 submissions · 48 cleared · Since 1978
48
Total
48
Cleared
0
Denied

Salter Labs — FDA 510(k) Submissions

Salter Labs has submitted 48 FDA 510(k) premarket notifications since 1978, of which 48 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Nebulizer (direct Patient Interface), Analyzer, Gas, Carbon-dioxide, Gaseous-phase, Conserver, Oxygen, Analyzer, Gas, Oxygen, Gaseous-phase, Cannula, Nasal, Oxygen . Use the specialty filter in the sidebar to narrow results.

48 devices
1–25 of 48
Salter Labs Bubble Humidifier
K161719 · BTT Humidifier, Respiratory... · Anesthesiology
Sep 2017 456d
BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal
K151874 · MNR Ventilatory Effort Recorder · Anesthesiology
Apr 2016 281d
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
K151506 · NFB Conserver, Oxygen · Anesthesiology
Mar 2016 281d
Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
K151421 · CCK Analyzer, Gas,... · Anesthesiology
Mar 2016 287d
CPAP Cannulaide
K143700 · BZD Ventilator,... · Anesthesiology
Aug 2015 224d
Luma Wrap
K142416 · PDH Blanket, Neonatal... · General Hospital
Jun 2015 288d
PNEUMOTHERML, MODEL: 5800
K092685 · BZQ Monitor, Breathing Frequency · Anesthesiology
Nov 2009 83d
BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
K051313 · MNR Ventilatory Effort Recorder · Anesthesiology
Sep 2005 119d
SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM
K040202 · BZD Ventilator,... · Anesthesiology
Mar 2005 400d
SALTER LABS MODIFIED NEBUTECH NEBULIZER
K014056 · CAF Nebulizer (direct Patient... · Anesthesiology
Feb 2002 53d
SALTER AIRE COMPRESSOR
K992285 · CAF Nebulizer (direct Patient... · Anesthesiology
Jan 2000 184d
SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER
K992986 · CAF Nebulizer (direct Patient... · Anesthesiology
Sep 1999 21d
SALTER LABS PEP DEVICE
K991788 · CAF Nebulizer (direct Patient... · Anesthesiology
Aug 1999 73d
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K990678 · NFB Conserver, Oxygen · Anesthesiology
May 1999 66d
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
K983403 · CAF Nebulizer (direct Patient... · Anesthesiology
Dec 1998 81d
SALTERLABS 8660 SERIES NEBULIZER
K962879 · CAF Nebulizer (direct Patient... · Anesthesiology
Oct 1996 90d
SALTER LABS 8990 SERIES NEBULIZER
K962085 · CAF Nebulizer (direct Patient... · Anesthesiology
Aug 1996 89d
SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
K961476 · CAF Nebulizer (direct Patient... · Anesthesiology
Jul 1996 89d
SALTER LABS INFANT NASAL CPAP CANNULA
K912434 · BZD Ventilator,... · Anesthesiology
Jul 1991 57d
SALTER LABS NEONATAL NASAL OXYGEN CANNULA
K911740 · CAT Cannula, Nasal, Oxygen · Anesthesiology
Jul 1991 98d
SALTER LABS DISPOSABLE NIPPLE AND NUT
K912174 · CAN Regulator, Pressure, Gas... · Anesthesiology
Jul 1991 69d
SALTER LABS INFANT MEDIUM CONCENTRATION MASK
K912633 · BYG Mask, Oxygen · Anesthesiology
Jul 1991 35d
SALTER LABS MODEL #1015
K903539 · CBH Device, Fixation,... · Anesthesiology
Dec 1990 132d
SALTER LABS MODEL #4009 SAMPLE LINES
K894350 · CCK Analyzer, Gas,... · Anesthesiology
Oct 1989 81d
MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA
K892406 · CCK Analyzer, Gas,... · Anesthesiology
Jul 1989 108d
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