Data / Medical devices / Israel / SHL TeleMedicine International
SHL TeleMedicine International: FDA-registered device maker in Tel-Aviv Tel Aviv, Israel, 5 510(k) clearances
SHL TeleMedicine International is registered with the FDA (registration 3003647588) in Tel-Aviv Tel Aviv, Israel. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 22, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003647588
- Address
- 90 Igal Alon Street, Tel-Aviv Tel Aviv, Israel, 67891
- Owner or operator
- SHL TeleMedicine International Ltd (10023481)
- Roles
- Manufacturer
- First device listed
- November 27, 2007
- Registered through
- 2026
- Brand names listed
- CARDIO MONITOR CENTER VISION, CARDIOVISION SOFTWARE,, CCM and Receiving Software, Cardio'R, CardioSenC, MODEL S-CV5-96, MODEL S-CV7-00, Smartheart and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 22, 2012 | K113514 | SMARTHEART | DXH | Substantially Equivalent | Shl Telemedicine International , Ltd. | accessdata.fda.gov |
| July 11, 2008 | K080047 | CARDIOSEN'C | DXH | Substantially Equivalent | Shl Telemedicine International , Ltd. | accessdata.fda.gov |
| September 12, 2007 | K063609 | RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER | DXH | Substantially Equivalent | Shl Telemedicine International , Ltd. | accessdata.fda.gov |
| January 25, 2001 | K003392 | CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 | DPS | Substantially Equivalent | Shl Telemedicine International , Ltd. | accessdata.fda.gov |
| August 19, 1998 | K981807 | CARDIOVISION SOFTWARE, MODEL S-CV5-96 | DPS | Substantially Equivalent | Shl Telemedicine International , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrocardiograph
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Medical Device Data System
Updated February 22, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.