FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
K Number: K974679
·
Decision Mar 23, 1998
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
198
Applicant Total
4
Review Days
98
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Basic Information
- Device Name
- THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
- K Number
- K974679
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcon , Ltd.
- Date Received
- December 15, 1997
- Decision Date
- March 23, 1998
- Product Code
- IZI
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | FDA class 2 | Radiology |
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