The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for 4k Uhd Lcd Monitor Oev321uh.
| Device ID | K220069 |
| 510k Number | K220069 |
| Device Name: | 4K UHD LCD Monitor OEV321UH |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Elizabeth Greene Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-10 |
| Decision Date | 2022-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170418723 | K220069 | 000 |