FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)
K Number: K963725
·
Decision Sep 10, 1997
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
1
Review Days
415
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Basic Information
- Device Name
- MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)
- K Number
- K963725
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Card Guard , Ltd.
- Date Received
- July 22, 1996
- Decision Date
- September 10, 1997
- 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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