The following data is part of a premarket notification filed by Biocare Bio-medical Equipment Co., Ltd. with the FDA for Digital Electrocardiograph.
| Device ID | K171517 |
| 510k Number | K171517 |
| Device Name: | Digital Electrocardiograph |
| Classification | Electrocardiograph |
| Applicant | Biocare Bio-Medical Equipment Co., Ltd. #16-1, Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan New District Shenzhen, CN 518102 |
| Contact | Hongbo Zhong |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-24 |
| Decision Date | 2018-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06937683413879 | K171517 | 000 |