The following data is part of a premarket notification filed by Birtcher Medical Systems, Inc. with the FDA for Birtcher Gs-9480 Integrated 3-chip Camera/xenon Light Source Visualization System.
| Device ID | K933319 |
| 510k Number | K933319 |
| Device Name: | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | BIRTCHER MEDICAL SYSTEMS, INC. 41 BROOKS DR. Braintree, MA 02184 |
| Contact | Eileen M Anderson |
| Correspondent | Eileen M Anderson BIRTCHER MEDICAL SYSTEMS, INC. 41 BROOKS DR. Braintree, MA 02184 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-07 |
| Decision Date | 1993-10-27 |