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 |