FDA 510(k) Applications Submitted by Jigar Shah
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090336 |
02/10/2009 |
SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS |
SUNMAX ENTERPRISE SHANGHAI CO. LTD. |
| K110737 |
03/16/2011 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 |
BIONIME CORPORATION |
| K100797 |
03/22/2010 |
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS |
EDAN INSTRUMENTS, INC. |
| K121093 |
04/10/2012 |
D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 |
DXM CO., LTD. |
| K101232 |
05/03/2010 |
JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001 |
JOINSOON ELECTRONICS MFG CO LTD |
| K101322 |
05/11/2010 |
JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001 |
JOINSOON ELECTRONICS MFG CO LTD |
| K121800 |
06/19/2012 |
POINT 500 HD POINT500C HD |
POINTNIX CO., LTD |
| K101833 |
07/01/2010 |
INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 |
INFIMED, INC. |
| K101870 |
07/06/2010 |
SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE |
SUNMAX VIETNAM CO. LTD |
| K202018 |
07/21/2020 |
Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation |
Hill-Rom, Inc. |
| K142163 |
08/06/2014 |
MALE CIRCUMCISION KITS:RAPIDECLAMP |
MEDICFIT TECHNOLOGY SDN BHD |
| K122589 |
08/24/2012 |
DFP4343C7 |
MDI CONSULTANTS, INC. |
| K133003 |
09/25/2013 |
RIGHTEST CONTROL SOLUTION |
BIONIME CORPORATION |
| K123008 |
09/27/2012 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN |
BIONIME CORPORATION |
| K093066 |
09/30/2009 |
I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 |
INFIMED, INC. |
| K223246 |
10/20/2022 |
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense |
Baxter Healthcare Corproration |
| K093375 |
10/29/2009 |
KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) |
KOON SENG SDN.BHD |
| K123517 |
11/14/2012 |
GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM |
SD BIOSENSOR |
| K123582 |
11/20/2012 |
ENDO A CLASS |
SAEYANG MICROTECH CO., LTD |
| K123608 |
11/21/2012 |
ENDO E CLASS |
SAEYANG MICROTECH CO., LTD |
| K103416 |
11/22/2010 |
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM |
INFIMED, INC. |
| K103675 |
12/16/2010 |
CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE |
CHIENMAX VIETNAM CO. LTD |
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