ISOLATED CAMERA HEAD
Device Facts
| Record ID | K944707 |
|---|---|
| Device Name | ISOLATED CAMERA HEAD |
| Applicant | Envision Medical Corp. |
| Product Code | FWF · General, Plastic Surgery |
| Decision Date | Oct 7, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4160 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A surgical camera and accessories is a device intended to be used to record operative procedures.