The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Visera Elite Ii Video System Center, Visera Elite Ii Hd 3cmos Autoclavable Camera Head, Visera Elite Ii 3cmos Camera Head.
| Device ID | K190449 |
| 510k Number | K190449 |
| Device Name: | Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head |
| 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 | Daphney Germain-kolawole 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-25 |
| Decision Date | 2019-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170393204 | K190449 | 000 |
| 04953170391408 | K190449 | 000 |
| 04953170386022 | K190449 | 000 |
| 04953170379611 | K190449 | 000 |
| 04953170386015 | K190449 | 000 |
| 04953170393112 | K190449 | 000 |