• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name thermometer, electronic, clinical
510(k) Number K121427
Device Name UNIMED TEMPERATURE PROBE
Original Applicant
UNIMED MEDICAL SUPPLIES INC.
no.37, yanshan road, shekou
shenzhen, guangdong,  CN 518067
Original Contact xinmei tan
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/14/2012
Decision Date 05/29/2012
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
-
-