The following data is part of a premarket notification filed by Fiegert-endotech Medizintechnik Gmbh with the FDA for Fiegert Endotech Flexible Fiberoptic Endoscopes, Fiegert Endotech Flexible Video-endoscopes.
| Device ID | K974493 |
| 510k Number | K974493 |
| Device Name: | FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | FIEGERT-ENDOTECH MEDIZINTECHNIK GMBH GAENSAECKER 42 Tuttlingen, DE D-78532 |
| Product Code | FDS |
| Subsequent Product Code | FAM |
| Subsequent Product Code | FDF |
| Subsequent Product Code | FDT |
| Subsequent Product Code | FEM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-28 |
| Decision Date | 1998-03-31 |