Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Imaging, Gastrointestinal, Wireless, Capsule
510(k) Number K142680
Device Name ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ISHIKAWA-CHO
HACHIOJI-SHI,  JP 192-8507
Applicant Contact Daphney Germain-Kolawole
Correspondent
OLYMPUS CORPORATION OF THE AMERICAS
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY,  PA  18034 -0610
Correspondent Contact Daphney Germain-Kolawole
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received09/19/2014
Decision Date 02/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-