FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FISK ARM SUPPORT
K Number: K931876
·
Decision Sep 9, 1993
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
5
Applicant Total
1
Review Days
148
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Basic Information
- Device Name
- FISK ARM SUPPORT
- K Number
- K931876
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vvortex International Corp.
- Date Received
- April 14, 1993
- Decision Date
- September 9, 1993
- Product Code
- FWW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FWW | Table, Operating-Room, Pneumatic | FDA class 1 | General, Plastic Surgery |
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