FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EK-VIEW(TM) ECG MANAGEMENT SYSTEM
K Number: K946115
·
Decision Mar 1, 1995
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
1
Review Days
76
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Basic Information
- Device Name
- EK-VIEW(TM) ECG MANAGEMENT SYSTEM
- K Number
- K946115
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Apcot Medical Systems
- Date Received
- December 15, 1994
- Decision Date
- March 1, 1995
- Product Code
- DXG
- 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 |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | FDA class 2 | Cardiovascular |
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