The following data is part of a premarket notification filed by Beijing East Whale Imaging Technology Co., Ltd with the FDA for Sigma P5/ Omega P7/ Lambda P9 Portable Ultrasound Diagnostic Scanner.
| Device ID | K160343 |
| 510k Number | K160343 |
| Device Name: | SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD B2-2 NEW CITY INDUSTRIAL PARK, NO.9 KECHUANG 2ND ST. YIZHUANG Beijing, CN 100023 |
| Contact | June Li |
| Correspondent | June Li BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD B2-2 NEW CITY INDUSTRIAL PARK, NO.9 KECHUANG 2ND ST. YIZHUANG Beijing, CN 100023 |
| 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 | 2016-02-08 |
| Decision Date | 2016-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970528550056 | K160343 | 000 |
| 06970528550049 | K160343 | 000 |
| 06970528550032 | K160343 | 000 |