The following data is part of a premarket notification filed by Shl Telemedicine International Ltd. with the FDA for River- 1 Electrocardiograph (ecg) Recorder And Transmitter.
| Device ID | K063609 |
| 510k Number | K063609 |
| Device Name: | RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | SHL TELEMEDICINE INTERNATIONAL LTD. 291 HILLSIDE AVE. Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub SHL TELEMEDICINE INTERNATIONAL LTD. 291 HILLSIDE AVE. Somerset, MA 02726 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-04 |
| Decision Date | 2007-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290008960267 | K063609 | 000 |