The following data is part of a premarket notification filed by Schoelly Fiberoptic, Gmbh with the FDA for Flexiscope Iq 101.
| Device ID | K992362 |
| 510k Number | K992362 |
| Device Name: | FLEXISCOPE IQ 101 |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | SCHOELLY FIBEROPTIC, GMBH 45 PONTIAC RD. Newton, MA 02248 |
| Contact | Joseph Ress |
| Correspondent | Joseph Ress SCHOELLY FIBEROPTIC, GMBH 45 PONTIAC RD. Newton, MA 02248 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-15 |
| Decision Date | 1999-08-05 |