510(k) K002001 ยท BZD Ventilator, Non-Continuous (Respirator)
BREEZE SLEEPGEAR WITH DREAMSEAL
| Applicant | Puritan Bennett Corp., Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 6, 2000 |
| Received | Jun 30, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002001
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.