The following data is part of a premarket notification filed by Gimmi Gmbh with the FDA for Gimmi'alpha' Endoscopes & Accessories.
| Device ID | K012660 |
| 510k Number | K012660 |
| Device Name: | GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | GIMMI GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
| Contact | Dagmar Maser |
| Correspondent | Dagmar Maser GIMMI GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
| Product Code | FET |
| Subsequent Product Code | EZO |
| Subsequent Product Code | FAJ |
| Subsequent Product Code | FAS |
| Subsequent Product Code | FBK |
| Subsequent Product Code | FBM |
| Subsequent Product Code | FCL |
| Subsequent Product Code | FDC |
| Subsequent Product Code | FDE |
| Subsequent Product Code | FED |
| Subsequent Product Code | FGC |
| Subsequent Product Code | FHA |
| Subsequent Product Code | FJL |
| Subsequent Product Code | GBZ |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | GCT |
| Subsequent Product Code | GEI |
| Subsequent Product Code | KNS |
| Subsequent Product Code | KOA |
| Subsequent Product Code | KOD |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2001-12-20 |
| Summary: | summary |