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 K081256
Device Name WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H
Applicant
Rio Flexon Technology Co., Ltd.
15f,868-2, Jhong Jheng Rd.,
Jhonghe City Taipei County,  TW 235
Applicant Contact CHI-HUNG LIAO
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFFREY D RONGERO
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/02/2008
Decision Date 05/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-