510(k) K864719 ยท BWF Spirometer, Therapeutic (Incentive)
PFLEX EM(TM) (EXERCISE MONITOR)
| Applicant | Health Products, Inc., Cedar Grove NJ, US |
| Decision | Substantially Equivalent, Mar 16, 1987 |
| Received | Dec 3, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864719
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.