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 Alarm, Conditioned Response Enuresis
510(k) Number K911279
Device Name DRY TIME
Applicant
Health Sense Intl., Inc.
201 S. Broadway
Coos Bay,  OR  97420
Applicant Contact LARRY F FISHER
Correspondent
Health Sense Intl., Inc.
201 S. Broadway
Coos Bay,  OR  97420
Correspondent Contact LARRY F FISHER
Regulation Number876.2040
Classification Product Code
KPN  
Date Received03/25/1991
Decision Date 09/04/1991
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
-
-