510(k) K965088 ยท ESD Hearing Aid, Air-Conduction, Prescription
M11 SERIES: M11, M11M
| Applicant | Philips Hearing Instruments Co., Mahwah NJ, US |
| Decision | Substantially Equivalent, Jan 24, 1997 |
| Received | Dec 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965088
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.