510(k) K101960 ยท HEP Monitor, Blood-Flow, Ultrasonic
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Aug 10, 2010 |
| Received | Jul 12, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101960
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.