The following data is part of a premarket notification filed by Dailycare Biomedical Inc with the FDA for Readmyheart, Model Rmh3.0.
| Device ID | K050620 |
| 510k Number | K050620 |
| Device Name: | READMYHEART, MODEL RMH3.0 |
| Classification | Electrocardiograph |
| Applicant | DAILYCARE BIOMEDICAL INC 8F, 25-3 JI-LIN ROAD Chungli, TW 320 |
| Contact | Daniel J Chang |
| Correspondent | Daniel J 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 | 2005-03-10 |
| Decision Date | 2005-07-14 |
| Summary: | summary |