The following data is part of a premarket notification filed by Sonoscape Company Limited with the FDA for S30/s40 Digital Color Doppler Ultraound System.
| Device ID | K150045 |
| 510k Number | K150045 |
| Device Name: | S30/S40 Digital Color Doppler Ultraound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SONOSCAPE COMPANY LIMITED YIZHE BLDG, YUQUAN ROAD NANSHAN DISTRICT Shenzhen, Guangdong, CN 518051 |
| Contact | Toki Wu |
| Correspondent | Toki Wu SONOSCAPE COMPANY LIMITED YIZHE BLDG, YUQUAN ROAD NANSHAN DISTRICT Shenzhen, Guangdong, CN 518051 |
| 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 | 2015-01-12 |
| Decision Date | 2015-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868614010 | K150045 | 000 |
| 06945868614003 | K150045 | 000 |
| 06945868613112 | K150045 | 000 |
| 06945868613105 | K150045 | 000 |
| 06945868601492 | K150045 | 000 |
| 06945868601270 | K150045 | 000 |
| 06945868601263 | K150045 | 000 |
| 06945868601188 | K150045 | 000 |