The following data is part of a premarket notification filed by Envision Medical Corp. with the FDA for Isolated Camera Head.
| Device ID | K944707 |
| 510k Number | K944707 |
| Device Name: | ISOLATED CAMERA HEAD |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | ENVISION MEDICAL CORP. 749 WARD DR. Santa Barbara, CA 93111 |
| Contact | Daniel P Mcguire |
| Correspondent | Daniel P Mcguire ENVISION MEDICAL CORP. 749 WARD DR. Santa Barbara, CA 93111 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-23 |
| Decision Date | 1994-10-07 |