The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Sonotrax Series Ultrasonic Pocket Doppler.
| Device ID | K101960 |
| 510k Number | K101960 |
| Device Name: | SONOTRAX SERIES ULTRASONIC POCKET DOPPLER |
| Classification | Monitor, Blood-flow, Ultrasonic |
| Applicant | EDAN INSTRUMENTS, INC. 3/F-B, NANSHAN MEDICAL EQUIPMENT PARK, NANHAI RD 1019 Shenzhen, CN 518067 |
| Contact | Yue Qiuhong |
| Correspondent | Yue Qiuhong EDAN INSTRUMENTS, INC. 3/F-B, NANSHAN MEDICAL EQUIPMENT PARK, NANHAI RD 1019 Shenzhen, CN 518067 |
| Product Code | HEP |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-12 |
| Decision Date | 2010-08-10 |
| Summary: | summary |