The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Video Bronchoscope Eb-j10 Series.
| Device ID | K200678 |
| 510k Number | K200678 |
| Device Name: | PENTAX Medical Video Bronchoscope EB-J10 Series |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-16 |
| Decision Date | 2020-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333251490 | K200678 | 000 |