FDA 510(k) Applications Submitted by SPACELABS HEALTHCARE LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K141113 04/30/2014 SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE SPACELABS HEALTHCARE LTD.
K152881 09/30/2015 SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM SPACELABS HEALTHCARE LTD.
K211651 05/28/2021 Eclipse PRO Spacelabs Healthcare Ltd.
K201921 07/10/2020 Spacelabs Lifescreen PRO Analyzer Spacelabs Healthcare Ltd.
K212317 07/26/2021 Eclipse MINI Model 98900 Spacelabs Healthcare Ltd.
K110001 01/03/2011 SPACELABS PATHFINDER SL HOLTER ANALYZER SPACELABS HEALTHCARE LTD.
K130207 01/28/2013 SPACELABS HEALTHCARE CARDIOEXPRESS SPACELABS HEALTHCARE LTD.
K101850 07/01/2010 SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION SPACELABS HEALTHCARE LTD.
K103732 12/22/2010 SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR SPACELABS HEALTHCARE LTD.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact