The following data is part of a premarket notification filed by Laser-optik-systeme Gmbh & Co. Kg with the FDA for Portable Endoscopy System.
| Device ID | K950712 |
| 510k Number | K950712 |
| Device Name: | PORTABLE ENDOSCOPY SYSTEM |
| Classification | Endoscope, Rigid |
| Applicant | LASER-OPTIK-SYSTEME GMBH & CO. KG AM SAGEWERK 11 Mainz, DE 55124 |
| Product Code | GCM |
| Subsequent Product Code | EOB |
| Subsequent Product Code | ERA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-14 |
| Decision Date | 1996-05-14 |