Medical Device Manufacturer · US , Sharonville , OH

Cincinnati Sub-Zero Products, Inc.

12 submissions · 12 cleared · Since 1991
12
Total
12
Cleared
0
Denied

Cincinnati Sub-Zero Products, Inc. — FDA 510(k) Submissions

Cincinnati Sub-Zero Products, Inc. has submitted 12 FDA 510(k) premarket notifications since 1991, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Thermal Regulating, Continuous Measurement Thermometer, Stethoscope, Esophageal, With Electrical Conductors, Controller, Temperature, Cardiopulmonary Bypass . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
K123946 · DWJ System, Thermal Regulating · Cardiovascular
Jan 2013 27d
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
K122813 · DWC Controller, Temperature,... · Cardiovascular
Dec 2012 96d
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
K121669 · DWJ System, Thermal Regulating · Cardiovascular
Jul 2012 27d
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
K120081 · DWJ System, Thermal Regulating · Cardiovascular
Feb 2012 37d
BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
K110104 · DWJ System, Thermal Regulating · Cardiovascular
Feb 2011 22d
WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS
K101148 · DWJ System, Thermal Regulating · Cardiovascular
Oct 2010 161d
BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
K101589 · DWJ System, Thermal Regulating · Cardiovascular
Sep 2010 105d
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
K072621 · BZT Stethoscope, Esophageal,... · Anesthesiology
Dec 2007 87d
DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES
K070339 · FLL Continuous Measurement... · General Hospital
Sep 2007 233d
WARM AIR WARMING UNIT
K942599 · DWJ System, Thermal Regulating · Cardiovascular
Jan 1995 237d
WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133)
K942790 · DWJ System, Thermal Regulating · Cardiovascular
Jan 1995 225d
WARMAIR SYSTEM
K910327 · DWJ System, Thermal Regulating · Cardiovascular
May 1991 111d
Filters