The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Video Esophagoscope Ee17-j10.
| Device ID | K223072 |
| 510k Number | K223072 |
| Device Name: | PENTAX Medical Video Esophagoscope EE17-J10 |
| Classification | Esophagoscope (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 | EOX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-30 |
| Decision Date | 2022-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333246083 | K223072 | 000 |