K101960 is an FDA 510(k) clearance for the SONOTRAX SERIES ULTRASONIC POCKET DOPPLER. This device is classified as a Monitor, Blood-flow, Ultrasonic (Class II - Special Controls, product code HEP).
Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on August 10, 2010, 29 days after receiving the submission on July 12, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K101960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2010 |
| Decision Date | August 10, 2010 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | HEP — Monitor, Blood-flow, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2660 |