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 K851146
Device Name DIGITAL THERMOMETER
Applicant
Micro Idea Instrument Co., Ltd.
R. 501, No 147, Sec. 2
Chien Kuo
North Road Taipei, Taiwan,  TW
Applicant Contact LIN
Correspondent
Micro Idea Instrument Co., Ltd.
R. 501, No 147, Sec. 2
Chien Kuo
North Road Taipei, Taiwan,  TW
Correspondent Contact LIN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/21/1985
Decision Date 05/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-