The following data is part of a premarket notification filed by Pentax Medical Company with the FDA for Entax Ultrasound Video Bronchoscope Eb-1970uk + Hi Visin Preirus.
| Device ID | K131946 |
| 510k Number | K131946 |
| Device Name: | ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | PENTAX MEDICAL COMPANY 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Contact | Krishna Govindarajan |
| Correspondent | Krishna Govindarajan PENTAX MEDICAL COMPANY 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2014-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333232208 | K131946 | 000 |
| 04961333227112 | K131946 | 000 |
| 04961333147670 | K131946 | 000 |