The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Eb-1970uk Ultrasound Video Bronchoscope + Hitachi Noblus And Hi Vision Preirus.
| Device ID | K183654 |
| 510k Number | K183654 |
| Device Name: | PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS And HI VISION Preirus |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | PENTAX Of America, Inc. 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Contact | William Goeller |
| Correspondent | William Goeller PENTAX Of America, Inc. 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-27 |
| Decision Date | 2019-05-23 |