• 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 system, x-ray, mobile
510(k) Number K061685
Device Name PULSERA
Original Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 bothell everett hwy.
p.o. box 3003, ms 915
bothell,  WA  98041 -3003
Original Contact joseph s arnaudo
Regulation Number892.1720
Classification Product Code
IZL  
Date Received06/15/2006
Decision Date 09/15/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-