The following data is part of a premarket notification filed by Schoelly Fiberoptic, Gmbh with the FDA for Cmos Video Nasopharyngoscope System.
| Device ID | K132009 |
| 510k Number | K132009 |
| Device Name: | CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | SCHOELLY FIBEROPTIC, GMBH 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau, Rac |
| Correspondent | Pamela Papineau, Rac SCHOELLY FIBEROPTIC, GMBH 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 | 2013-07-01 |
| Decision Date | 2014-04-09 |
| Summary: | summary |