The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for S60 Elite Series/s70 Series Digital Color Doppler Ultrasound System.
| Device ID | K201059 |
| 510k Number | K201059 |
| Device Name: | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Sonoscape Medical Corp. Room 201 & 202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Rd, Yuehai Subdistrict,Nanshan District Shenzhen, CN 518057 |
| Contact | Toki Wu |
| Correspondent | Toki Wu Sonoscape Medical Corp. Room 201 & 202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Rd, Yuehai Subdistrict,Nanshan District Shenzhen, CN 518057 |
| 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 | 2020-04-21 |
| Decision Date | 2020-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868603366 | K201059 | 000 |
| 06945868602994 | K201059 | 000 |
| 06945868603250 | K201059 | 000 |
| 06945868603267 | K201059 | 000 |
| 06945868603274 | K201059 | 000 |
| 06945868603281 | K201059 | 000 |
| 06945868603298 | K201059 | 000 |
| 06945868603304 | K201059 | 000 |
| 06945868603311 | K201059 | 000 |
| 06945868603328 | K201059 | 000 |
| 06945868603335 | K201059 | 000 |
| 06945868603342 | K201059 | 000 |
| 06945868603359 | K201059 | 000 |
| 06945868602987 | K201059 | 000 |