510(k) K964360 ยท BZC Calculator, Pulmonary Function Data
VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
| Applicant | Novametrix Medical Systems, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Apr 4, 1997 |
| Received | Nov 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964360
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.