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, telethermographic (adjunctive use)
510(k) Number K200999
Device Name Thermidas IR System (ThIR-A615)
Applicant
Thermidas Americas, Inc.
7912 Sailboat Key Blvd., Suite 508
South Pasadena,  FL  33707
Applicant Contact Karo Kujanpaa
Correspondent
Gunster, Yoakley & Stewart, P.A.
225 Water Street, Suite 1750
Jacksonville,  FL  32202
Correspondent Contact Samantha L Prokop
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received04/16/2020
Decision Date 01/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-