WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS— 510(k) K101148
Substantially EquivalentCincinnati Sub-Zero Products, Inc.
FDA 510(k) clearance K101148 for WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS, Substantially Equivalent on 2010-10-01. Applicant: Cincinnati Sub-Zero Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Cincinnati Sub-Zero Products, Inc.
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sharonville, OH, US
Recent devices under product code DWJ
view allMore clearances from Cincinnati Sub-Zero Products, Inc.
view all- K123946 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
- K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
- K121669 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
- K120081 — NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
- K110104 — BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
Adverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.