510(k) K974751 ยท ESD Hearing Aid, Air-Conduction, Prescription
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
| Applicant | General Hearing Instruments, Inc., Harahan LA, US |
| Decision | Substantially Equivalent, Mar 6, 1998 |
| Received | Dec 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974751
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.