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 K921062
Device Name GAELTEC MPR SERIES
Applicant
Medical Measurements, Inc.
53 Main St.
Hackensack,  NJ  07601
Applicant Contact WILLIAM SONES
Correspondent
Medical Measurements, Inc.
53 Main St.
Hackensack,  NJ  07601
Correspondent Contact WILLIAM SONES
Regulation Number876.1725
Classification Product Code
FFX  
Date Received03/05/1992
Decision Date 07/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-