The following data is part of a premarket notification filed by Shenzhen Carewell Electronics., Ltd with the FDA for Ai-ecg Platform.
| Device ID | K180432 |
| 510k Number | K180432 |
| Device Name: | AI-ECG Platform |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Shenzhen Carewell Electronics., Ltd 2/F, Building 1, Glory Medical Industrial Park NO.2, Baolong Road 5, Longgang Shenzhen, CN 518116 |
| Contact | Chang Liu |
| Correspondent | Arthur Goddard FDA Regulatory And Quality Systems Consultant 31853 Cedar Road Mayfield Heights, OH 44124 -4445 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-11-19 |
| Summary: | summary |