The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for 4k Camera Head Olympus Ch-s400-xz-eb, 4k Autoclavable Camera Head Olympus Ch-s400-xz-ea.
Device ID | K172817 |
510k Number | K172817 |
Device Name: | 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA |
Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
Contact | Toshiyuki Nakajima |
Correspondent | Sheri L. Musgnung Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
Product Code | FET |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-18 |
Decision Date | 2017-10-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170375552 | K172817 | 000 |
04953170374609 | K172817 | 000 |