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 thermometer, electronic, clinical
510(k) Number K102934
Device Name INFRARED EAR THERMOMETER, MODEL IR-04MT
Applicant
VEGA TECHNOLOGIES, INC.
11F-13, 100 CHANG-CHUN RD.
TAIPEI,  TW 104
Applicant Contact JOSEPH LU
Correspondent
VEGA TECHNOLOGIES, INC.
11F-13, 100 CHANG-CHUN RD.
TAIPEI,  TW 104
Correspondent Contact JOSEPH LU
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/04/2010
Decision Date 01/14/2011
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
-
-