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, thermal regulating
510(k) Number K201779
Device Name HotDog Temperature Management Controller
Applicant
Augustine Temperature Management
7656 West 78th Street
Minneapolis,  MN  55439
Applicant Contact Temi Ogunse
Correspondent
Augustine Temperature Management
7656 West 78th Street
Minneapolis,  MN  55439
Correspondent Contact Temi Ogunse
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/30/2020
Decision Date 09/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-