FDA 510(k) Applications Submitted by STEPHEN GORSKI
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070193 |
01/22/2007 |
ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES |
ENVITEC-WISMAR GMBH |
| K060315 |
02/08/2006 |
HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
| K110393 |
02/11/2011 |
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W |
EKF-DIAGNOSTIC GMBH |
| K090438 |
02/20/2009 |
REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR |
ENVITEC-WISMAR GMBH |
| K050595 |
03/08/2005 |
FT2000 SEQUENCER FOR MUSCLE STIMULATOR |
MIDWEST DEVELOPMENT |
| K060675 |
03/14/2006 |
ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS |
ENVITEC-WISMAR GMBH |
| K101002 |
04/12/2010 |
A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
| K041035 |
04/21/2004 |
HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND |
HOFFRICHTER GMBH |
| K041548 |
06/09/2004 |
SENTEC DIGITAL MONITOR MODEL #SDM |
SENTEC INC. |
| K051546 |
06/13/2005 |
BPCALIBRATOR MC3000/MC3100 |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
| K131788 |
06/18/2013 |
HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
| K031898 |
06/19/2003 |
EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM |
EKF DIAGNOSTIC GMBH |
| K131916 |
06/26/2013 |
BPROSOFT CASP PC SOFTWARE |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
| K122290 |
07/30/2012 |
ENVITEC MYSIGN O OXYGEN MEASURING DEVICE |
ENVITEC-WISMAR GMBH |
| K072136 |
08/02/2007 |
ULTRASONIC NEBULISER MODEL 2010 |
WILFRED KROMKER GMBH |
| K102270 |
08/10/2010 |
ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN |
ENVITEC-WISMAR GMBH |
| K082655 |
09/12/2008 |
ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 |
ENVITEC-WISMAR GMBH |
| K072593 |
09/14/2007 |
A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
| K133064 |
09/27/2013 |
MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 |
ENVITEC-WISMAR GMBH |
| K043463 |
12/15/2004 |
ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS |
ENVITEC-WISMAR GMBH |
| K960251 |
01/18/1996 |
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR |
ARISTO MEDICAL PRODUCTS, INC. |
| K961060 |
03/18/1996 |
ARISTO ESOPHAGEAL STETHOSCOPE |
ARISTO MEDICAL PRODUCTS, INC. |
| K101690 |
06/16/2010 |
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE |
SENTEC AG |
| K071672 |
06/19/2007 |
SENTEC DIGITAL MONITORING SYSTEM |
SENTEC AG |
| K992215 |
07/01/1999 |
MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED |
ENVITEC-WISMAR GMBH |
| K083185 |
10/29/2008 |
CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1 |
CADI SCIENTIFIC PTE.LTD |
| K103584 |
12/07/2010 |
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS |
SHENZHEN ENVISEN INDUSTRY CO. LIMITED |
| K014074 |
12/10/2001 |
HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION |
HOFFRICHTER GMBH |
| K053486 |
12/15/2005 |
TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET |
HOFFRICHTER GMBH |
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