The following data is part of a premarket notification filed by Sonoscape Company Limited with the FDA for A6 Portable Ultrasonic Diagnostic System.
| Device ID | K101337 |
| 510k Number | K101337 |
| Device Name: | A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SONOSCAPE COMPANY LIMITED 5D, #19 LANE 999, ZHONGSHAN ROAD 9S-2) Shanghai, CN 20030 |
| Contact | Diana Hong |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-05-12 |
| Decision Date | 2010-09-30 |
| Summary: | summary |