The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Electrocardiograph.
| Device ID | K212278 |
| 510k Number | K212278 |
| Device Name: | Electrocardiograph |
| Classification | Electrocardiograph |
| Applicant | Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
| Contact | Ying Dai |
| Correspondent | Joan Wei Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-20 |
| Decision Date | 2022-04-07 |