FDA 510(k) Applications Submitted by THOMAS KROENKE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110001 |
01/03/2011 |
SPACELABS PATHFINDER SL HOLTER ANALYZER |
SPACELABS HEALTHCARE LTD. |
| K130112 |
01/16/2013 |
CAPNO MODULE, 92517 |
SPACELABS HEALTHCARE |
| K130207 |
01/28/2013 |
SPACELABS HEALTHCARE CARDIOEXPRESS |
SPACELABS HEALTHCARE LTD. |
| K120616 |
02/29/2012 |
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 |
SPACELABS MEDICAL, INC. |
| K090556 |
03/02/2009 |
SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE |
SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO |
| K130707 |
03/15/2013 |
ISIRONA MAGELLAN |
ISIRONA, LLC |
| K110779 |
03/21/2011 |
SPACELABS SMART DISCLOSURE SYSTEM |
SPACELABS HEALTHCARE |
| K121017 |
04/04/2012 |
CAPNOGRAPHY PAD (92516) |
SPACELABS HEALTHCARE |
| K141156 |
05/05/2014 |
SPACELABS HEALTHCARE TELEMETRY RECEIVER |
SPACELABS HEALTHCARE |
| K041239 |
05/11/2004 |
GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 |
GENESIS MEDICAL TECHNOLOGY, INC. |
| K121480 |
05/18/2012 |
ARIATELE TELEMETRY TRANSMITTER (96281) |
SPACELABS HEALTHCARE |
| K101850 |
07/01/2010 |
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION |
SPACELABS HEALTHCARE LTD. |
| K061931 |
07/07/2006 |
SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101 |
SOLARIS MEDICAL TECHNOLOGY, INC. |
| K112047 |
07/18/2011 |
AMCOM COMMTECH MESSENGER |
AMCOM SOFTWARE,INC. |
| K122146 |
07/19/2012 |
XHIBIT CENTRAL STATION, MODEL 96102 |
SPACELABS HEALTHCARE |
| K112173 |
07/28/2011 |
SPEACELABS MULTIGAS MODULE |
SPACELABS HEALTHCARE |
| K012641 |
08/13/2001 |
FAS ENDOLUMINAL BRUSH |
FAS MEDICAL LTD. |
| K112650 |
09/12/2011 |
CONNEXALL SUITE OF SOFTWARE PRODUCTS |
CONNEXALL USA, INC. |
| K112729 |
09/20/2011 |
BLEASE700/900 SERIES VENTILATORS |
SPACELABS HEALTHCARE |
| K092928 |
09/23/2009 |
DOSE VOLUME HISTOGRAM (DVH) EVALUATOR |
DIVERSILABS, LLC |
| K083010 |
10/09/2008 |
SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR |
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
| K113051 |
10/13/2011 |
SPACELABS ARKON ANESTHESIA WORKSTATION |
SPACELABS HEALTHCARE |
| K133147 |
10/17/2013 |
BRACCO INJEENERING TRANSFER SET |
BRACCO INJENEERING S.A. |
| K103142 |
10/25/2010 |
SPACELABS MULTI-PARAMETER MODULE |
SPACELABS HEALTHCARE, INC. |
| K103634 |
12/13/2010 |
ASCOM CLINICALCONNEX CARDIOMAX |
ASCOM (US), INC. |
| K103732 |
12/22/2010 |
SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR |
SPACELABS HEALTHCARE LTD. |
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