• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K952073
Device Name PACI-TEMP, PACIFIER WITH DIGITAL THERMOMETER
Original Applicant
INTELLIGENT PRODUCT LIMITED CO.
463 north orem blvd.
orem,  UT  84057
Original Contact matthew kho
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/02/1995
Decision Date 12/18/1995
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-