The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Evs-endoscopic Video Image & Data Sys.
| Device ID | K853585 |
| 510k Number | K853585 |
| Device Name: | OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Terry J Hartl |
| Correspondent | Terry J Hartl OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-26 |
| Decision Date | 1986-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170071348 | K853585 | 000 |
| 04953170064180 | K853585 | 000 |
| 04953170063886 | K853585 | 000 |