The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Ent Video Imaging System.
| Device ID | K162151 |
| 510k Number | K162151 |
| Device Name: | PENTAX Medical ENT Video Imaging System |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | PENTAX OF AMERICA, INC. 3 PARAGON DRIVE Montvale, NJ 07645 -1782 |
| Contact | Krishna Govindarajan |
| Correspondent | Krishna Govindarajan PENTAX OF AMERICA, INC. 3 PARAGON DRIVE Montvale, NJ 07645 -1782 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-02 |
| Decision Date | 2017-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333233960 | K162151 | 000 |
| 04961333233809 | K162151 | 000 |