510(k) K020641 ยท BZD Ventilator, Non-Continuous (Respirator)
SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001
| Applicant | Worldwide Medical Technologies, LLC, Waycross GA, US |
| Decision | Substantially Equivalent, Oct 29, 2002 |
| Received | Feb 27, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020641
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.