FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
RADIFORCE LARGE MONITOR SYSTEM
K Number: K112645
·
Decision Sep 22, 2011
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
77
Applicant Total
3
Review Days
10
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Basic Information
- Device Name
- RADIFORCE LARGE MONITOR SYSTEM
- K Number
- K112645
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eizo GmbH
- Date Received
- September 12, 2011
- Decision Date
- September 22, 2011
- Product Code
- DXJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXJ | Display, Cathode-Ray Tube, Medical | FDA class 2 | Cardiovascular |
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