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 monitor, esophageal motility, anorectal motility, and tube
510(k) Number K120088
Device Name MCOMPASS ANORECTAL MANOMETRY SYSTEM
Applicant
MEDSPIRA, LLC
2718 SUMMER STREET NE
MINNEAPOLIS,  MN  55413
Applicant Contact JIM QUACKENBUSH
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number876.1725
Classification Product Code
KLA  
Date Received01/11/2012
Decision Date 03/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
-
-