510(k) K021716 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
SIMPLIFY COMPACT RESUSCITATOR
| Applicant | Polymed (Xiamen) Plastic Industrial Co., Ltd., Xiamen, CN |
| Decision | Substantially Equivalent, Oct 8, 2002 |
| Received | May 23, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021716
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.