510(k) K021328 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
SMART BAG MO
| Applicant | O-Two Systems International, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Jun 26, 2003 |
| Received | Apr 26, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021328
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.