FDA 510(k) Applications Submitted by J. HARVEY KNAUSS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K983680 |
10/20/1998 |
TRINITY II SINGLE CHAMBER DVT PUMP |
DELPHI CONSULTING GROUP |
| K122162 |
07/20/2012 |
AGGREGUIDE |
AGGREDYNE, INC. |
| K970014 |
01/02/1997 |
TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.) |
DELPHI CONSULTING GROUP |
| K130002 |
01/02/2013 |
SURECALL LABOR MONITOR |
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP |
| K030077 |
01/08/2003 |
GISH TUBING AND CONNECTORS WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K090145 |
01/21/2009 |
SURECALL EMG LABOR MONITOR |
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP |
| K080178 |
01/24/2008 |
VALVULOTOME BY KOVEN |
KOVEN TECHNOLOGY, INC. |
| K050195 |
01/27/2005 |
V-BAG WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K090295 |
02/05/2009 |
BODYVIZ, MODEL 100 |
VISUAL MEDICAL SOLUTIONS, LLC |
| K040355 |
02/12/2004 |
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K010452 |
02/15/2001 |
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T |
KOVEN TECHNOLOGY, INC. |
| K000609 |
02/23/2000 |
CARDTEL, MODEL NT-100 |
CARDIAC TELECOMMUNICATIONS |
| K030726 |
03/07/2003 |
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K050601 |
03/09/2005 |
SMARTDOP 45 VASCULAR DOPPLER |
KOVEN TECHNOLOGY, INC. |
| K961301 |
04/04/1996 |
E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120 |
DELPHI CONSULTING GROUP |
| K060962 |
04/07/2006 |
ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 |
BYRNE MEDICAL, INC. |
| K031300 |
04/24/2003 |
IBC FLOPUMP WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K991571 |
05/05/1999 |
10 CURIE IRDIUM 192, CSN00100-192 |
ALPHA-OMEGA SERVICES, INC. |
| K091343 |
05/06/2009 |
MRI NEURO DRAPE |
SURGIVISION, INC. |
| K031504 |
05/14/2003 |
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX |
KOVEN TECHNOLOGY, INC. |
| K091439 |
05/14/2009 |
HEAD FIXATION ARC AND TABLE BASE |
SURGIVISION, INC. |
| K961937 |
05/20/1996 |
SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM |
DELPHI CONSULTING GROUP |
| K031773 |
06/09/2003 |
ENDO GATOR SYSTEM |
BYRNE MEDICAL, INC. |
| K982034 |
06/10/1998 |
E-FAX SYSTEM |
BLAKBAG, LTD., DIVISION OF COHERENT SYSTEMS |
| K131721 |
06/12/2013 |
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 |
COMED MEDICAL SYSTEMS CO., LTD |
| K051606 |
06/16/2005 |
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K031931 |
06/23/2003 |
ECHO SOUNDER EX-101EX 8 MHZ |
KOVEN TECHNOLOGY, INC. |
| K041755 |
06/29/2004 |
CROMAX HIGH SPEED TURBINE HANDPIECE |
J.R. MEDICAL TECHNOLOGIES, INC. |
| K032379 |
08/01/2003 |
QUASAR, MODEL MD21 |
QUANTUM SKINCARE, INC. |
| K023143 |
09/20/2002 |
ECHO SOUNDER, ES-102EX |
KOVEN TECHNOLOGY, INC. |
| K983355 |
09/23/1998 |
SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR |
SABRATEK CORP. |
| K072722 |
09/26/2007 |
MEDDORNA WIRELESS PRN SPIROMETER 100 |
MEDDORNA LLC |
| K954489 |
09/27/1995 |
TRINITY SLEEVE(S) |
DELPHI CONSULTING GROUP |
| K963957 |
10/02/1996 |
TRINITY DVT SYSTEM |
DELPHI CONSULTING GROUP |
| K023381 |
10/08/2002 |
VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING |
GISH BIOMEDICAL, INC. |
| K083179 |
10/28/2008 |
MEDILED PHOTOTHERAPY LAMP |
MEDIX I.C.S.A. |
| K023833 |
11/18/2002 |
GISH ARTERIAL FILTER WITH GBS COATING |
GISH BIOMEDICAL, INC. |
| K033695 |
11/25/2003 |
IRRIGATION CHANNEL TUBING, MODEL 100135 |
BYRNE MEDICAL, INC. |
| K972572 |
07/10/1997 |
SINGLE LUMEN EMBOLECTOMY CATHETER |
AMERICAN BIOMED, INC. |
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