510(k) K083377 ยท HKX Tonometer, Ac-Powered
ACCUPEN
| Applicant | Accutome Ultrasound, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jul 27, 2009 |
| Received | Nov 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083377
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.