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 |