FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIS-2000 VIDEO SYSTEM
K Number: K860173
·
Decision Feb 7, 1986
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
1
Applicant Total
5
Review Days
21
Basic Information
- Device Name
- VIS-2000 VIDEO SYSTEM
- K Number
- K860173
- 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
- January 17, 1986
- Decision Date
- February 7, 1986
- Product Code
- FWG
- 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 |
|---|---|---|---|
| FWG | Camera, Television, Endoscopic, With Audio | FDA class 1 | General, Plastic Surgery |
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