510(k) K920353 ยท HEP Monitor, Blood-Flow, Ultrasonic
ULTRACELL INSTRUMENT WIPE
| Applicant | Ultracell Medical Technologies, Inc., North Stonington CT, US |
| Decision | Substantially Equivalent, Sep 15, 1992 |
| Received | Jan 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920353
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.