510(k) K961077 ยท BWF Spirometer, Therapeutic (Incentive)
PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
| Applicant | Healthscan Products, Inc., Cedar Grove NJ, US |
| Decision | Substantially Equivalent, Jul 15, 1996 |
| Received | Mar 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961077
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.