KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS
FDA 510(k) clearance K033021 · decided 2003-11-12
Clearance details
- K-number
- K033021
- Device name
- KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS
- Applicant
- Kimberly-Clark Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-26
- Decision date
- 2003-11-12
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- DWJ
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal r recall (Z-0451-2013) | Kimberly-Clark Corporation | 2012-11-29 |
| Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Wa recall (Z-2181-2012) | Kimberly-Clark Corporation | 2012-08-09 |