The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Endocapsule Software 10; Endocapsule Software 10 Light.
| Device ID | K142680 |
| 510k Number | K142680 |
| Device Name: | ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji-shi, JP 192-8507 |
| Contact | Daphney Germain-kolawole |
| Correspondent | Daphney Germain-kolawole OLYMPUS CORPORATION OF THE AMERICAS 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 | 2014-09-19 |
| Decision Date | 2015-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170373845 | K142680 | 000 |
| 14953170373807 | K142680 | 000 |
| 14953170373760 | K142680 | 000 |