• 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 | Inspections

New Search Back To Search Results
Device Classification Name monitor,physiological,patient(without arrhythmia detection or alarms)
510(k) Number K032338
Device Name TRIO MONITOR MODEL 0998-00-0600
Original Applicant
800 macarthur blvd.
mahwah,  NJ  07430 -0619
Original Contact susan e mandy
Regulation Number870.2300
Classification Product Code
Date Received07/29/2003
Decision Date 02/11/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls