510(k) K853971 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
REGULATOR-INHALATOR SYSTEM
| Applicant | Stephenson Industries, Inc., Farmingdale NJ, US |
| Decision | Substantially Equivalent, Dec 9, 1985 |
| Received | Sep 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853971
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.