The following data is part of a premarket notification filed by Pentax Medical with the FDA for Pentax Medical Epk-3000 Video Imaging System.
Device ID | K172156 |
510k Number | K172156 |
Device Name: | PENTAX Medical EPK-3000 Video Imaging System |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | Pentax Medical 3 Paragon Drive Montvale, NJ 07645 |
Contact | William Goeller |
Correspondent | James W. Monroe 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 | 2017-07-18 |
Decision Date | 2018-04-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04961333245284 | K172156 | 000 |
04961333244874 | K172156 | 000 |
04961333251315 | K172156 | 000 |
04961333251148 | K172156 | 000 |
04961333221417 | K172156 | 000 |
04961333221370 | K172156 | 000 |
04961333221325 | K172156 | 000 |
04961333251223 | K172156 | 000 |
04961333230662 | K172156 | 000 |
04961333226153 | K172156 | 000 |
04961333221455 | K172156 | 000 |
04961333221448 | K172156 | 000 |
04961333134359 | K172156 | 000 |
04961333134052 | K172156 | 000 |
04961333077984 | K172156 | 000 |
04961333075164 | K172156 | 000 |
04961333070367 | K172156 | 000 |
04961333249176 | K172156 | 000 |
14961333221438 | K172156 | 000 |
14961333221612 | K172156 | 000 |
04961333245277 | K172156 | 000 |
04961333245260 | K172156 | 000 |
04961333245253 | K172156 | 000 |
04961333245246 | K172156 | 000 |
04961333245239 | K172156 | 000 |
04961333245222 | K172156 | 000 |
04961333245215 | K172156 | 000 |
04961333245208 | K172156 | 000 |
04961333243426 | K172156 | 000 |
04961333240456 | K172156 | 000 |
04961333240449 | K172156 | 000 |
04961333240425 | K172156 | 000 |
04961333225408 | K172156 | 000 |
04961333225354 | K172156 | 000 |
04961333225316 | K172156 | 000 |
04961333225262 | K172156 | 000 |
14961333221650 | K172156 | 000 |
04961333251636 | K172156 | 000 |