FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
DISCOSCOPES, CERVICAL ENDOSCOPES
K Number: K130778
·
Decision Apr 14, 2014
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
3
Review Days
389
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Basic Information
- Device Name
- DISCOSCOPES, CERVICAL ENDOSCOPES
- K Number
- K130778
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rz Medizintechnik GmbH
- Date Received
- March 21, 2013
- Decision Date
- April 14, 2014
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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