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 |