Futura 67M, 68M, MEGAPOWERMP97, Integra 70, 71, 72, 73, Supra 51, 52, Supra 56, 57, 58, 59, Suprema 45, 46, 47, 48
by Magnatone Hearing Aid Corp.
510(k) K973861
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973861 | Date19 Nov 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ESD
- Device Class
- Class I
- Regulation
- 21 CFR Part 874.3300
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent