510(k) K971492 ยท HIG Insufflator, Hysteroscopic
AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR
| Applicant | Bei Medical Systems Co., Inc., Hackensack NJ, US |
| Decision | Substantially Equivalent, Sep 5, 1997 |
| Received | Apr 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971492
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.