Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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(with arrhythmia detection or alarms)
510(k) Number K112962
Device Name SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
Applicant
SPACELABS MEDICAL INC.
5150 220TH AVE SE
ISSAQUAH,  WA  98029
Applicant Contact DAVVID J GERAGHTY
Correspondent
SPACELABS MEDICAL INC.
5150 220TH AVE SE
ISSAQUAH,  WA  98029
Correspondent Contact DAVVID J GERAGHTY
Regulation Number870.1025
Classification Product Code
MHX  
Date Received10/05/2011
Decision Date 11/02/2011
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
-
-