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 |