The following data is part of a premarket notification filed by Frigitronics, Inc. with the FDA for Hc-series Medical Camera/light Source And Accessor.
| Device ID | K905393 |
| 510k Number | K905393 |
| Device Name: | HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | FRIGITRONICS, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose FRIGITRONICS, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-30 |
| Decision Date | 1991-01-16 |