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 |