FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
SMARTHEART
K Number: K113514
·
Decision Feb 22, 2012
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
5
Review Days
86
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Basic Information
- Device Name
- SMARTHEART
- K Number
- K113514
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shl Telemedicine International , Ltd.
- Date Received
- November 28, 2011
- Decision Date
- February 22, 2012
- Product Code
- DXH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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Other Clearances by Shl Telemedicine International , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K080047 | CARDIOSEN'C | Jul 11, 2008 | Substantially Equivalent |
| K063609 | RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER | Sep 12, 2007 | Substantially Equivalent |
| K003392 | CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 | Jan 25, 2001 | Substantially Equivalent |
| K981807 | CARDIOVISION SOFTWARE, MODEL S-CV5-96 | Aug 19, 1998 | Substantially Equivalent |