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 K850196
Device Name COPAL DIGITAL THERMOMETER UF-22B
Applicant
Takeda Medical, Inc.
17945 Skypark Cir.
Irvine,  CA  92714
Applicant Contact MICHAEL OHSAWA
Correspondent
Takeda Medical, Inc.
17945 Skypark Cir.
Irvine,  CA  92714
Correspondent Contact MICHAEL OHSAWA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/18/1985
Decision Date 02/07/1985
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
-
-