FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
PS SERIES
K Number: K061622
·
Decision Mar 5, 2007
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
25
Applicant Total
1
Review Days
266
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Basic Information
- Device Name
- PS SERIES
- K Number
- K061622
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Photonic Optische Gerate Gesmbh & Cokg
- Date Received
- June 12, 2006
- Decision Date
- March 5, 2007
- Product Code
- FFS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FFS | Image, Illumination, Fiberoptic, For Endoscope | FDA class 2 | Gastroenterology, Urology |
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