The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Epk-3000 Imaging System With Camera Head Pvk-j10, Pentax Medical Ent Imaging System With Camera Head Pvk-j10.
| Device ID | K220465 |
| 510k Number | K220465 |
| Device Name: | PENTAX Medical EPK-3000 Imaging System With Camera Head PVK-J10, PENTAX Medical ENT Imaging System With Camera Head PVK-J10 |
| Classification | Nasopharyngoscope (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 | EOB |
| Subsequent Product Code | EQL |
| Subsequent Product Code | OUG |
| Subsequent Product Code | PEA |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-17 |
| Decision Date | 2022-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333246274 | K220465 | 000 |