Hyper-K Heat System
510(k) K912722
Hyper-K Heat System is a Class II device made by Baxter Healthcare Corp, cleared under FDA 510(k) K912722 on 11 Sep 1991, 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 | NumberK912722 | Date11 Sep 1991 | StatusActive |
Official records
- FDA 510(k) database K912722
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- Withdrawn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
- SESE Substantially Equivalent
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