510(k) K863353 ยท ETY Tester, Auditory Impedance
MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)
| Applicant | Grason-Stadler, Inc., Littleton MA, US |
| Decision | Substantially Equivalent, Nov 3, 1986 |
| Received | Aug 29, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863353
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.