The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Video Bronchoscopes, Pentax Medical Video Naso-pharyngo-laryngoscope, And Pentax Medical Ultrasond Video Bronchoscope.
| Device ID | K173554 |
| 510k Number | K173554 |
| Device Name: | PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, And PENTAX Medical Ultrasond Video Bronchoscope |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | PENTAX Of America, Inc. 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Contact | James W. Monroe |
| Correspondent | James W. Monroe PENTAX Of America, Inc. 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Product Code | EOQ |
| Subsequent Product Code | EOB |
| Subsequent Product Code | ITX |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-17 |
| Decision Date | 2018-01-19 |
| Summary: | summary |