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 Electrode, Ph, Stomach
510(k) Number K811083
Device Name ESOPHAGEAL MOTILITY PROBE
Applicant
Konigsberg Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Konigsberg Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.1400
Classification Product Code
FFT  
Date Received04/21/1981
Decision Date 08/13/1981
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
-
-