510(k) K912153 ยท ESD Hearing Aid, Air-Conduction, Prescription
QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR
| Applicant | Qualitone, Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 17, 1991 |
| Received | May 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912153
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.