The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Ultrasound Video Bronchoscope Eb19-j10u.
| Device ID | K183516 |
| 510k Number | K183516 |
| Device Name: | PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | PENTAX Of America, Inc. 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Contact | William Goeller |
| Correspondent | Beryl St. Jeanne NAMSA Inc. 400 Highway 169, Suite 500 Minneapolis, MN 55426 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-18 |
| Decision Date | 2019-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333222162 | K183516 | 000 |
| 84961333253940 | K183516 | 000 |
| 04961333232130 | K183516 | 000 |
| 04961333222223 | K183516 | 000 |
| 04961333222216 | K183516 | 000 |