The following data is part of a premarket notification filed by Dailycare Biomedical, Inc with the FDA for Checkmyheart Plus.
| Device ID | K172778 |
| 510k Number | K172778 |
| Device Name: | CheckMyHeart Plus |
| Classification | Electrocardiograph |
| Applicant | DailyCare Biomedical, Inc 7f, No. 1, Ding-An Rd, Zhongli Dist. Taoyuan City Taoyuan, TW 320 |
| Contact | Ming Da Lee |
| Correspondent | Ming Da Lee DailyCare Biomedical, Inc 7f, No. 1, Ding-An Rd, Zhongli Dist. Taoyuan City Taoyuan, TW 320 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-14 |
| Decision Date | 2018-07-05 |
| Summary: | summary |