Thermocool System
by Zimmer, Inc.
510(k) K950395
Thermocool System is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K950395 on 18 Aug 1995, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK950395 | Date18 Aug 1995 | StatusActive |
Official records
- FDA 510(k) database K950395
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ILO
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5720
- Advisory committee
- Physical Medicine
- FDA decision
- SN
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