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, gastrointestinal motility (electrical)
510(k) Number K222000
Device Name Transit-Pellets
Applicant
Medifactia AB
C/O IOffice Buisness Center Kungsgatan 60
Stockholm,  SE 11122
Applicant Contact Diana Nystrom
Correspondent
M Squared Associates Inc.
127 West 30th Street
9th Floor
New York,  NY  10001
Correspondent Contact Cherita James
Regulation Number876.1725
Classification Product Code
FFX  
Date Received07/07/2022
Decision Date 01/18/2023
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
-
-