The following data is part of a premarket notification filed by Schoelly Fiberoptic Gmbh with the FDA for Cmos Video Nasopharyngoscope System.
| Device ID | K143673 |
| 510k Number | K143673 |
| Device Name: | CMOS Video Nasopharyngoscope System |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Schoelly Fiberoptic Gmbh Robert-Bosch-Str. 1-3 Denzlingen, DE 79211 |
| Contact | Dr. Sandra Baumann |
| Correspondent | Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-03-04 |
| Summary: | summary |