FDA 510(k) Applications for Medical Device:
System, Gastrointestinal Motility (Electrical)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K201106 | AnX Robotica Corp. |
1047 Serpentine Ln. Suite 100, Pleasanton | Pleasanton | CA | 94566 |
| K191087 | AnX Robotica Corp. |
7213 Regency Court | Plano | TX | 75204 |
| K223705 | Covidien LLC |
3062 Bunker Hill Lane | Santa Clara | CA | 95054 |
| K231861 | Covidien LLC |
3062 Bunker Hill Lane | Santa Clara | CA | 95054 |
| K183072 | Crospon Ltd |
Galway Business Park, Dangan | Galway | ||
| K160725 | CROSPON LTD. |
GALWAY BUSINESS PARK, DANGAN | GALWAY | ||
| K170833 | Crospon Ltd. |
Galway Business Park, Dangan | Galway | ||
| K120997 | CROSPON, LTD. |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K102214 | CROSPON, LTD. |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K092850 | CROSPON, LTD. |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K130906 | CROSPON, LTD. |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K980946 | DENTSLEEVE PTY., LTD. |
56 A/B GLEN OSMOND RD. | PARKSIDE SOUTH AUSTRALIA | 5063 | |
| K013154 | DENTSLEEVE PTY., LTD. |
13605 WEST 7TH AVE. | GOLDEN | CO | 80401-4604 |
| K190208 | Diversatek Healthcare |
9150 Commerce Center Circle | Highlands Ranch | CO | 80129 |
| K102801 | E-CATH CO., LTD |
13605 WEST 7TH AVENUE | GOLDEN | CO | 80401 |
| K991288 | G & J ELECTRONICS, INC. |
6 DORNFELL ST. | TORONTO, ONTARIO | M2R 2Y6 | |
| K973844 | G & J ELECTRONICS, INC. |
6 DORNFELL ST. | TORONTO, ONTARIO | M2R 2Y6 | |
| K151086 | GIVEN IMAGING LTD. |
2 HACARMEL ST. NEW INDUSTRIAL PARK POB 258 | YOQNEAM | 20962 | |
| K980980 | KONIGSBERG INSTRUMENTS, INC. |
2000 FOOTHILL BLVD. | PASADENA | CA | 91107 |
| K181750 | Konsyl Pharmaceuticals |
050 Industrial Park Road | Easton | MD | 21601 |
| K963064 | LABORIE MEDICAL TECH CORP. |
6 HURRICANE LANE, #2 | WILLISTON | VT | 05495 |
| K082056 | LIFE-TECH, INC. |
4235 GREENBRIAR DR. | STAFFORD | TX | 77477-3995 |
| K071094 | MEDICAL MEASUREMENT SYSTEMS,B.V. |
COLOSSEUM 25 | ENSCHEDE | 7521 PV | |
| K060166 | MEDICAL MEASUREMENT SYSTEMS,B.V. |
COLOSSEUM 25 | ENSCHEDE | 7521 PV | |
| K052338 | MEDICAL MEASUREMENT SYSTEMS,B.V. |
COLOSSEUM 25 | ENSCHEDE | 7521 PV | |
| K121014 | MEDICAL MEASUREMENT SYSTEMS,B.V. |
COLOSSEUM 25 | ENSCHEDE | 7521 PV | |
| K031084 | MEDICAL MEASUREMENT SYSTEMS,B.V. |
COLOSSEUM 25 | ENSCHEDE | 7521 PV | |
| K222000 | Medifactia AB |
C/O IOffice Buisness Center Kungsgatan 60 | Stockholm | 11122 | |
| K181760 | Medifactia AB |
Sahlgrenska Science Park | Gothenburg | SE-413 90 | |
| K991389 | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
TONSBAKKEN 16-18 | COPENHAGEN | DK-2740 | |
| K011471 | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
16-18 TONSBAKKEN | SKOVLUNDE | DK-2740 | |
| K981733 | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
16-18 TONSBAKKEN | SKOVLUNDE | DK-2740 | |
| K992713 | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
16-18 TONSBAKKEN | SKOVLUNDE | DK-2740 | |
| K000386 | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
16-18 TONSBAKKEN | SKOVLUNDE | DK-2740 | |
| K011472 | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
16-18 TONSBAKKEN | SKOVLUNDE | DK-2740 | |
| K010130 | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
16-18 TONSBAKKEN | SKOVLUNDE | DK-2740 | |
| K972439 | MEDTRONIC-SYNECTICS |
RENSTIEMAS GATA 12 | STOCKHOLM | S-116 28 | |
| K122294 | MUI SCIENTIFIC |
145 TRADERS BLVD. EAST, # 34 | MISSISSAUGA | L4Z 3L3 | |
| K160287 | MUI SCIENTIFIC |
145 TRADERS BLVD. EAST #33-34 | MISSISSAUGA | L4Z 3L3 | |
| K120524 | MUI SCIENTIFIC |
145 TRADERS BLVD. EAST | MISSISSAUGA | L4Z 3L3 | |
| K004040 | RED-TECH, INC. |
27881 LA PAZ RD. | LAGUNA NIGUEL | CA | |
| K984444 | SANDHILL SCIENTIFIC, INC. |
8955 SOUTH RIDGELINE BLVD., | HIGHLANDS RANCH | CO | 80126 |
| K990441 | SANDHILL SCIENTIFIC, INC. |
8955 SOUTH RIDGELINE BLVD., | HIGHLANDS RANCH | CO | 80126 |
| K012232 | SANDHILL SCIENTIFIC, INC. |
4655 KIRKWOOD CT | BOULDER | CO | 80301 |
| K002427 | SANDHILL SCIENTIFIC, INC. |
9150 COMMERCE CENTER CIR.,#500 | HIGHLANDS RANCH | CO | 80129 |
| K942247 | SANDHILL SCIENTIFIC, INC. |
1501-N WEST CAMPUS DR. | LITTLETON | CO | 80120-4535 |
| K091070 | SIERRA SCIENTIFIC INSTRUMENTS, INC. |
5757 CENTURY BLVD. | LOS ANGELES | CA | 90045 |
| K031169 | SIERRA SCIENTIFIC INSTRUMENTS, INC. |
16787 BERNARDO CENTER DR. | SAN DIEGO | CA | 92128 |
| K003580 | UNISENSOR AG |
13605 WEST 7TH AVE. | GOLDEN | CO | 80401-4604 |
| K062222 | UNISENSOR AG |
13605 WEST 7TH AVE. | GOLDEN | CO | 80401-4604 |
| K160170 | Wilson-Cook Medical, Inc. |
4900 Bethania Station Road | Winston-Salem | NC | 27105 |
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