The following data is part of a premarket notification filed by Dailycare Biomedical Inc with the FDA for Readmyheart, Model Rmh2.0.
Device ID | K052303 |
510k Number | K052303 |
Device Name: | READMYHEART, MODEL RMH2.0 |
Classification | Electrocardiograph |
Applicant | DAILYCARE BIOMEDICAL INC 8F, 25-3 JI-LIN ROAD Chungli, TW 320 |
Contact | Daniel J. H. Chang |
Correspondent | Daniel J. H. Chang DAILYCARE BIOMEDICAL INC 8F, 25-3 JI-LIN ROAD Chungli, 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 | 2005-08-24 |
Decision Date | 2005-12-16 |
Summary: | summary |