FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIS-1000 VIDEO SYSTEM
K Number: K843806
·
Decision Dec 12, 1984
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
17
Applicant Total
5
Review Days
76
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Basic Information
- Device Name
- VIS-1000 VIDEO SYSTEM
- K Number
- K843806
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Vistek Corp.
- Date Received
- September 27, 1984
- Decision Date
- December 12, 1984
- Product Code
- KQM
- 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 |
|---|---|---|---|
| KQM | Camera, Surgical And Accessories | FDA class 1 | General, Plastic Surgery |
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