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 |