510(k) K983643 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
GENESIS BLS
| Applicant | O-Two Systems Intl., Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Oct 29, 1998 |
| Received | Oct 16, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K983643
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.