Thermo-K
by American Medical Systems, Inc.
510(k) K820814
Thermo-K is a Class II device made by American Medical Systems, Inc., cleared under FDA 510(k) K820814 on 29 Apr 1982, 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)SESE | NumberK820814 | Date29 Apr 1982 | StatusActive |
Official records
- FDA 510(k) database K820814
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DWJ
- Device class
- Class II
- Regulation
- 21 CFR Part 870.5900
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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