The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Sonobook Series Diagnostic Ultrasound System.
Device ID | K170374 |
510k Number | K170374 |
Device Name: | SonoBook Series Diagnostic Ultrasound System |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | CHISON Medical Imaging Co., Ltd. NO.228, ChangJiang East Road,Block 51 And 53, Phase 5 Industrial Park ShouFa Wuxi, CN 214142 |
Contact | Qifei Liu |
Correspondent | Bob Leiker Leiker Regulatory & Quality Consulting 4157 North Del Ray Ave Clovis, CA 93619 |
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 | 2017-02-07 |
Decision Date | 2017-06-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06945121412681 | K170374 | 000 |
06945121411561 | K170374 | 000 |
06945121411554 | K170374 | 000 |
06945121411547 | K170374 | 000 |
06945121411530 | K170374 | 000 |
06945121411523 | K170374 | 000 |
06945121411516 | K170374 | 000 |
06945121411509 | K170374 | 000 |
06945121411493 | K170374 | 000 |
06945121411486 | K170374 | 000 |
06945121411479 | K170374 | 000 |
06945121411462 | K170374 | 000 |
06945121411455 | K170374 | 000 |
06945121411172 | K170374 | 000 |
06945121413305 | K170374 | 000 |
06945121411578 | K170374 | 000 |
06945121411585 | K170374 | 000 |
06945121411592 | K170374 | 000 |
06945121412230 | K170374 | 000 |
06945121411998 | K170374 | 000 |
06945121411714 | K170374 | 000 |
06945121411707 | K170374 | 000 |
06945121411691 | K170374 | 000 |
06945121411684 | K170374 | 000 |
06945121411677 | K170374 | 000 |
06945121411660 | K170374 | 000 |
06945121411653 | K170374 | 000 |
06945121411646 | K170374 | 000 |
06945121411639 | K170374 | 000 |
06945121411622 | K170374 | 000 |
06945121411615 | K170374 | 000 |
06945121411608 | K170374 | 000 |
06945121414166 | K170374 | 000 |