510(k) K860173
- Device
- VIS-2000 VIDEO SYSTEM
- Applicant
- VISTEK CORP.
- 510(k) number
- K860173
- Product code
- FWG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-07
- Date received
- 1986-01-17
- Regulation
- 878.4160
- Classification name
- Camera, Television, Endoscopic, With Audio
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK R COLLINS
- Address
- 4 E. Yanonali St. Santa Barbara CA US 93101 93101
FDA Registration Numbers#
- 3031240334
- 8010573
- 2518897
- 3038284218
- 9611102
- 3007593944
- 3008699634
- 3013011598
- 3039523130
- 3006680097
- 3005527904
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FWG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K934883 | 3D VIDEO SYSTEM | Richard Wolf Medical Instruments Corp. | 1994-03-07 |
Legacy Summary#
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FDA Review#
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