The following data is part of a premarket notification filed by Dailycare Biomedical Inc with the FDA for Readmyheart.
| Device ID | K042814 |
| 510k Number | K042814 |
| Device Name: | READMYHEART |
| Classification | Electrocardiograph |
| Applicant | DAILYCARE BIOMEDICAL INC 3892 S. AMERICA WEST TRAIL Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich DAILYCARE BIOMEDICAL INC 3892 S. AMERICA WEST TRAIL Flagstaff, AZ 86001 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-12 |
| Decision Date | 2005-01-06 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() READMYHEART 78613181 3231061 Live/Registered |
DAILYCARE BIOMEDICAL INC. 2005-04-20 |