• 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 monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K063419
Device Name MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )
Applicant
WELCH ALLYN PROTOCOL, INC.
8500 S.W. CREEKSIDE PLACE
BEAVERTON,  OR  97008 -7107
Applicant Contact JEFFREY WAGNER
Correspondent
WELCH ALLYN PROTOCOL, INC.
8500 S.W. CREEKSIDE PLACE
BEAVERTON,  OR  97008 -7107
Correspondent Contact JEFFREY WAGNER
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/13/2006
Decision Date 12/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-