• 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 monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K121367
Model ZOLL PROPAQ XM
Device Name ZOLL PROPAQ XM
Original Applicant
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford,  MA  01824
Original Contact charles w kolifrath
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CCK   DPS   DQA   DXN   FLL  
Date Received05/07/2012
Decision Date 06/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
-
-