The following data is part of a premarket notification filed by Dailycare Biomedical Inc with the FDA for Instantcheck Rtd-ecg Monitor, Model Rmh4.0.
| Device ID | K062894 |
| 510k Number | K062894 |
| Device Name: | INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 |
| 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 | 2006-09-27 |
| Decision Date | 2007-02-08 |
| Summary: | summary |