The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Video System Center.
| Device ID | K122831 |
| 510k Number | K122831 |
| Device Name: | VIDEO SYSTEM CENTER |
| Classification | Led Light Source |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | NTN |
| Subsequent Product Code | FET |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-17 |
| Decision Date | 2012-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170338502 | K122831 | 000 |
| 04953170338496 | K122831 | 000 |