510(k) K001553 ยท BZD Ventilator, Non-Continuous (Respirator)
BREAS PV 100 CPAP SYSTEM
| Applicant | Vital Signs, Inc., Totowa NJ, US |
| Decision | Substantially Equivalent, Aug 3, 2000 |
| Received | May 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001553
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.