The following data is part of a premarket notification filed by Marks & Murase with the FDA for Epx-310 Video Processor (endoscopy).
Device ID | K950417 |
510k Number | K950417 |
Device Name: | EPX-310 VIDEO PROCESSOR (ENDOSCOPY) |
Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
Applicant | MARKS & MURASE 399 PARK AVE. New York, NY 10022 -4689 |
Contact | Gary A Adler |
Correspondent | Gary A Adler MARKS & MURASE 399 PARK AVE. New York, NY 10022 -4689 |
Product Code | FET |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-31 |
Decision Date | 1995-07-21 |