The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Olympus Capsule Endoscope System.
| Device ID | K063259 |
| 510k Number | K063259 |
| Device Name: | OLYMPUS CAPSULE ENDOSCOPE SYSTEM |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-30 |
| Decision Date | 2007-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170214332 | K063259 | 000 |