FDA 510(k) Applications Submitted by KRISTA OAKES
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070217 |
01/23/2007 |
INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE |
NEURO RESOURCE GROUP, INC. |
| K960728 |
02/22/1996 |
ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE) |
NEUROMED, INC. |
| K090472 |
02/24/2009 |
GRIND GUARD |
ARCHTEK, INC. |
| K100669 |
03/09/2010 |
CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES |
US MEDICAL INNOVATIONS LLC |
| K010718 |
03/12/2001 |
FLEXI-SITE SP02 EAR SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
| K000831 |
03/14/2000 |
STAT-SHELL DISPOSABLE SP02 SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
| K061191 |
04/28/2006 |
FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2 |
MEASUREMENT SPECIALTIES, INC. |
| K971928 |
05/27/1997 |
QUEST VESSEL CATHETER |
QUEST MEDICAL, INC. |
| K041522 |
06/07/2004 |
FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS |
ELEKON INDUSTRIES U.S.A., INC. |
| K041644 |
06/17/2004 |
FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) |
ELEKON INDUSTRIES U.S.A., INC. |
| K041647 |
06/17/2004 |
FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) |
ELEKON INDUSTRIES U.S.A., INC. |
| K992092 |
06/21/1999 |
STAT-SHELL DISPOSABLE SPO2 SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
| K081835 |
06/27/2008 |
ACTICARE IC AND TSE |
BIOINDUCTION LIMITED |
| K992211 |
07/01/1999 |
SPO2 WRAP SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
| K051964 |
07/20/2005 |
POWERNEB |
COMEDICA , INC. |
| K041964 |
07/21/2004 |
MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS |
MEDIAID INC. |
| K002223 |
07/24/2000 |
EPIC SPO2 FINGER SENSOR, MODEL E412-20 |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
| K012333 |
07/24/2001 |
FLEXI-SITE SP02 EAR SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
| K992811 |
08/20/1999 |
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
| K002848 |
09/13/2000 |
SPO2 WRAP SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
| K042675 |
09/29/2004 |
FLEXI-STAT SP02 EAR SENSOR |
ELEKON INDUSTRIES U.S.A., INC. |
| K042704 |
09/30/2004 |
REUSABLE FINGER CLIP SPO2 SENSORS |
ELEKON INDUSTRIES U.S.A., INC. |
| K042705 |
09/30/2004 |
DISPOSABLE NON-ADHESIVE SPO2 SENSORS |
ELEKON INDUSTRIES U.S.A., INC. |
| K042912 |
10/21/2004 |
INTERX5000 |
NEURO RESOURCE GROUP, INC. |
| K955818 |
12/26/1995 |
FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER |
QUEST MEDICAL, INC. |
| K053626 |
12/28/2005 |
INTERX500 FLEXIBLE ARRAY ELECTRODE |
NEURO RESOURCE GROUP, INC. |
| K043614 |
12/30/2004 |
VACULINK, MODEL VCL 3000 |
MEDEVCO, INC. |
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