The following data is part of a premarket notification filed by Sonoscape Company Limited with the FDA for S6 Diagnostic Ultrasound System.
| Device ID | K112602 |
| 510k Number | K112602 |
| Device Name: | S6 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SONOSCAPE COMPANY LIMITED P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SONOSCAPE COMPANY LIMITED P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-07 |
| Decision Date | 2011-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868696016 | K112602 | 000 |
| 06945868696009 | K112602 | 000 |