510(k) K071221 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12
| Applicant | Automedx, Inc., Germantown MD, US |
| Decision | Substantially Equivalent, Sep 6, 2007 |
| Received | May 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071221
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.