The following data is part of a premarket notification filed by Pentax Medical with the FDA for Pentax Medical Vivideo Ent Videoscope Solution.
| Device ID | K171011 |
| 510k Number | K171011 |
| Device Name: | PENTAX Medical VIVIDEO ENT Videoscope Solution |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Pentax Medical 3 Paragon Drive Montvale, NJ 07645 |
| Contact | James W. Monroe |
| Correspondent | William Goeller Pentax Medical 3 Paragon Drive Montvale, NJ 07645 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-04 |
| Decision Date | 2018-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333221073 | K171011 | 000 |
| 04961333239795 | K171011 | 000 |
| 04961333221103 | K171011 | 000 |