The following data is part of a premarket notification filed by Shenzhen Carewell Electronics Co., Ltd. with the FDA for Ai-ecg Tracker.
| Device ID | K200036 |
| 510k Number | K200036 |
| Device Name: | AI-ECG Tracker |
| Classification | Electrocardiograph |
| Applicant | Shenzhen Carewell Electronics Co., Ltd. Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park Songbai Road, Xili Street Shenzhen, CN 518108 |
| Contact | Chang Liu |
| Correspondent | Arthur Goddard FDA Regulatory And Quality Systems Consultant 31853 Cedar Road Mayfield Heights, OH 44124 -4445 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-08 |
| Decision Date | 2020-03-20 |