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 K033967
FOIA Releasable 510(k) K033967
Device Name TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
Applicant
Flir Systems
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Applicant Contact PAUL DRYDEN
Correspondent
Flir Systems
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Correspondent Contact PAUL DRYDEN
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received12/22/2003
Decision Date 03/09/2004
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
Predetermined Change
Control Plan Authorized		 No
-
-