The following data is part of a premarket notification filed by Schoelly Fiberoptic Gmbh with the FDA for Schoelly Sinuscope.
| Device ID | K142249 |
| 510k Number | K142249 |
| Device Name: | SCHOELLY SINUSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| 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 AVE Ayer, MA 01432 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-14 |
| Decision Date | 2015-01-27 |
| Summary: | summary |