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 |