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 detector, dialysate level
510(k) Number K875312
Device Name UFR DIGITAL RETROFIT
Applicant
YANKEE INTL. MEDICAL RESEARCH & MFG., LTD.
P.O. BOX 151
MANCHESE,  NH  03105 -0151
Applicant Contact D. W BROUS
Correspondent
YANKEE INTL. MEDICAL RESEARCH & MFG., LTD.
P.O. BOX 151
MANCHESE,  NH  03105 -0151
Correspondent Contact D. W BROUS
Regulation Number876.5820
Classification Product Code
FJB  
Date Received12/29/1987
Decision Date 02/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-