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 Gastrointestinal Motility System, Capsule
510(k) Number K092342
Device Name SMARTPILL GI MONITORING SYSTEM, VERSION 2.0
Applicant
THE SMARTPILL CORPORATION
847 MAIN ST.
BUFFALO,  NY  14203 -1109
Applicant Contact KATHLEEN SELOVER
Correspondent
THE SMARTPILL CORPORATION
847 MAIN ST.
BUFFALO,  NY  14203 -1109
Correspondent Contact KATHLEEN SELOVER
Regulation Number876.1725
Classification Product Code
NYV  
Date Received08/04/2009
Decision Date 10/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT00603707
NCT00857363
Reviewed by Third Party No
Combination Product No
-
-