Cincinnati Sub-Zero Products, Inc. - FDA 510(k) Cleared Devices
Recent clearances: WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS, HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM, WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cincinnati Sub-Zero Products, Inc. Cardiovascular ✕
10 devices
Cleared
Jan 17, 2013
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
Cardiovascular
27d
Cleared
Dec 18, 2012
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
Cardiovascular
96d
Cleared
Jul 03, 2012
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
Cardiovascular
27d
Cleared
Feb 17, 2012
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
Cardiovascular
37d
Cleared
Feb 04, 2011
BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
Cardiovascular
22d
Cleared
Oct 01, 2010
WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS
Cardiovascular
161d
Cleared
Sep 20, 2010
BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
Cardiovascular
105d
Cleared
Jan 24, 1995
WARM AIR WARMING UNIT
Cardiovascular
237d
Cleared
Jan 24, 1995
WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133)
Cardiovascular
225d
Cleared
May 16, 1991
WARMAIR SYSTEM
Cardiovascular
111d