CARDIOSEN'C
Transmitters And Receivers, Electrocardiograph, Telephone
SHL TELEMEDICINE INTERNATIONAL LTD.
The following data is part of a premarket notification filed by Shl Telemedicine International Ltd. with the FDA for Cardiosen'c.
Pre-market Notification Details
| Device ID | K080047 |
| 510k Number | K080047 |
| Device Name: | CARDIOSEN'C |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | SHL TELEMEDICINE INTERNATIONAL LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy SHL TELEMEDICINE INTERNATIONAL LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-08 |
| Decision Date | 2008-07-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290008960250 | K080047 | 000 |
Trademark Results [CARDIOSEN'C]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIOSEN'C 78927956 not registered Dead/Abandoned |
SHL TELEMEDICINE INTERNATIONAL LTD. 2006-07-12 |
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