510(k) K012691 ยท CBK Ventilator, Continuous, Facility Use
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
| Applicant | Acutronic Medical Systems AG, Tucson AZ, US |
| Decision | Substantially Equivalent, Dec 20, 2002 |
| Received | Aug 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012691
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.