The following data is part of a premarket notification filed by Sonoscape Company Limited with the FDA for Portable Digital Color Doppler Ultrasound System.
| Device ID | K130119 |
| 510k Number | K130119 |
| Device Name: | PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SONOSCAPE COMPANY LIMITED Nanfeng Building, Nanshan Yungu Innovation Industrial Park No. 1183 Liuxian Avenue, Taoyuan Street, Nanshan District Shenzhen, CN 518055 |
| Contact | Toki Wu |
| Correspondent | Toki Wu SONOSCAPE COMPANY LIMITED Nanfeng Building, Nanshan Yungu Innovation Industrial Park No. 1183 Liuxian Avenue, Taoyuan Street, Nanshan District Shenzhen, CN 518055 |
| 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 | 2013-01-16 |
| Decision Date | 2013-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868612016 | K130119 | 000 |
| 06945868612009 | K130119 | 000 |
| 06945868601157 | K130119 | 000 |