The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc with the FDA for Tipcam 1s 3d System.
| Device ID | K162410 |
| 510k Number | K162410 |
| Device Name: | TIPCAM 1S 3D System |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | KARL STORZ Endoscopy America, Inc 2151 E.Grand Avenue El Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong 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 | 2016-08-29 |
| Decision Date | 2017-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551414644 | K162410 | 000 |
| 04048551385098 | K162410 | 000 |
| 04048551385081 | K162410 | 000 |