510(k) K983785 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
AUTOVENT 1000
| Applicant | O-Two Systems Intl., Inc., Ontario L5s 1c8, CA |
| Decision | Substantially Equivalent, Oct 29, 1998 |
| Received | Oct 27, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K983785
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.