The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Cmos Video-rhino-laryngoscope System.
| Device ID | K182186 |
| 510k Number | K182186 |
| Device Name: | CMOS Video-Rhino-Laryngoscope System |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Nozomi Yagi |
| Correspondent | Nozomi Yagi KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-13 |
| Decision Date | 2019-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551402405 | K182186 | 000 |