THERMOSUIT SYSTEM
FDA 510(k) clearance K061023 · decided 2006-09-20
Clearance details
- K-number
- K061023
- Device name
- THERMOSUIT SYSTEM
- Applicant
- Life Recovery Systems Hd, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-04-13
- Decision date
- 2006-09-20
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- NZE
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Durham, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ recall (Z-0456-2012) | Life Recovery Systems HD, LLC | 2012-01-11 |