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 Continuous Measurement Thermometer
510(k) Number K201977
Device Name TempTraq
Applicant
Blue Spark Technologies, Inc.
806 Sharon Dr., Suite G
Westlake,  OH  44145
Applicant Contact John Gannon
Correspondent
MethodSense, Inc.
1 Copley Pkwy.,
Suite 410
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/16/2020
Decision Date 12/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-