The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Visera Elite Ii Xenon Light Source, Telescope Ir/telescope Ultra, Visera Elite Ii Video System Center, Hd 3cmos Autoclavable Camera Head, Hd 3cmos Camera Head.
| Device ID | K200542 |
| 510k Number | K200542 |
| Device Name: | Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head |
| Classification | Confocal Optical Imaging |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Lisa M. Boyle Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | OWN |
| Subsequent Product Code | FET |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | HET |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2020-03-03 |
| Decision Date | 2020-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761086189 | K200542 | 000 |
| 04042761086172 | K200542 | 000 |
| 04042761083638 | K200542 | 000 |
| 04042761083621 | K200542 | 000 |
| 04953170386138 | K200542 | 000 |
| 04953170428142 | K200542 | 000 |
| 04953170393204 | K200542 | 000 |
| 04953170386022 | K200542 | 000 |
| 04953170379611 | K200542 | 000 |