510(k) K002465 ยท BZD Ventilator, Non-Continuous (Respirator)
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Sep 8, 2000 |
| Received | Aug 11, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002465
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.