• 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 -9501
Applicant Contact paul dryden
Correspondent
FLIR SYSTEMS
6329 W. WATERVIEW CT.
mccordsville,  IN  46055 -9501
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
-
-