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 Urinometer, Mechanical
510(k) Number K935578
Device Name URINE METER
Applicant
PURITAS HEALTH CARE, INC.
219 KENT RD.
SUITE 20
NEW MILFORD,  CT  06776
Applicant Contact THOMAS P DIMAIO
Correspondent
PURITAS HEALTH CARE, INC.
219 KENT RD.
SUITE 20
NEW MILFORD,  CT  06776
Correspondent Contact THOMAS P DIMAIO
Regulation Number876.1800
Classification Product Code
EXR  
Date Received11/18/1993
Decision Date 12/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-