The following data is part of a premarket notification filed by Schoelly Fiberoptic Gmbh with the FDA for Schoelly Cystoscopes/hysteroscopes And Accessories.
| Device ID | K201970 |
| 510k Number | K201970 |
| Device Name: | Schoelly Cystoscopes/Hysteroscopes And Accessories |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Schoelly Fiberoptic GmbH Robert-Bosch-Str. 1-3 Denzlingen, DE D-79211 |
| Contact | Sandra Baumann |
| Correspondent | Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-15 |
| Decision Date | 2020-10-08 |