510(k) K003927 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
| Applicant | Cheen Houng Ent. Co. , Ltd., Taipei (Shulin), TW |
| Decision | Substantially Equivalent, Jun 26, 2001 |
| Received | Dec 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003927
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.