The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Systems Integration.
Device ID | K102763 |
510k Number | K102763 |
Device Name: | SYSTEMS INTEGRATION |
Classification | Endoscopic Central Control Unit |
Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
Contact | Stacy Abbatiello |
Correspondent | Stacy Abbatiello OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
Product Code | ODA |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-24 |
Decision Date | 2011-02-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170291579 | K102763 | 000 |
04953170291555 | K102763 | 000 |
04953170291531 | K102763 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SYSTEMS INTEGRATION 73798618 1597966 Dead/Cancelled |
REED PUBLISHING (USA) INC. 1989-05-08 |