The following data is part of a premarket notification filed by Chison Medical Technologies Co., Ltd. with the FDA for Cbit Series Digital Color Doppler Ultrasound System.
| Device ID | K180974 |
| 510k Number | K180974 |
| Device Name: | CBit Series Digital Color Doppler Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | CHISON Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 And 53, Phase 5, Shuofang Industrial Park Wuxi, CN 214142 |
| Contact | Qifei Liu |
| Correspondent | Qifei Liu CHISON Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 And 53, Phase 5, Shuofang Industrial Park Wuxi, CN 214142 |
| 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 | 2018-04-13 |
| Decision Date | 2018-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945121412377 | K180974 | 000 |
| 06945121413220 | K180974 | 000 |
| 06945121413145 | K180974 | 000 |
| 06945121413039 | K180974 | 000 |
| 06945121412933 | K180974 | 000 |
| 06945121412407 | K180974 | 000 |
| 06945121412315 | K180974 | 000 |
| 06945121412322 | K180974 | 000 |
| 06945121412339 | K180974 | 000 |
| 06945121412346 | K180974 | 000 |
| 06945121412353 | K180974 | 000 |
| 06945121412360 | K180974 | 000 |
| 06945121413435 | K180974 | 000 |