FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
DECLIPSESPECT VIEWER
K Number: K123917
·
Decision Jan 25, 2013
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
29
Applicant Total
3
Review Days
37
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Basic Information
- Device Name
- DECLIPSESPECT VIEWER
- K Number
- K123917
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 892.1320
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Surgiceye GmbH
- Date Received
- December 19, 2012
- Decision Date
- January 25, 2013
- Product Code
- IZD
- 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 |
|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | FDA class 1 | Radiology |
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