FDA 510(k) Applications for Medical Device:
Flowmeter, Blood, Cardiovascular
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K972213 | ALAN S. LEE |
2121 W BEACON AVE. | ANAHEIM | CA | 92804 |
| K031153 | ARROW INTL., INC. |
2400 BERNVILLE RD. | READING | PA | 19605 |
| K013803 | BIOSONIX LTD. |
BEIT HAPA'AMON (BOX 124) | KFAR SABA | 44425 | |
| K041180 | CARDIOSONIX, LTD. |
BEIT HAPA'AMON (BOX 124) | KFAR SABA | 44425 | |
| K023431 | CARDIOSONIX, LTD. |
BEIT HAPA'AMON (BOX 124) | KFAR SABA | 44425 | |
| K030357 | CARDIOSONIX, LTD. |
BEIT HAPA'AMON (BOX 124) | KFAR SABA | 44425 | |
| K110347 | COOK VASCULAR, INC. |
1186 MONTGOMERY LANE | VANDERGRIFT | PA | 15690 |
| K051145 | CRITISENSE LTD. |
6329 W. WATERVIEW CT. | MCCORDSVILLE | IN | 46055-9501 |
| K062977 | CRITISENSE LTD. |
3460 POINTE CREEK CT. | BONITA SPRINGS | FL | 34134-2015 |
| K031706 | DELTEX MEDICAL |
TERMINUS RD. | CHICHESTER, WEST SUSSEX | PO19 8TX | |
| K111542 | DELTEX MEDICAL LIMITED |
BIOPARK, BROADWATER ROAD | HERTSFORDSHIRE | AL7 3AX | |
| K150347 | DELTEX MEDICAL LIMITED |
TERMINUS RD. | CHICHESTER | PO19 8TX | |
| K132139 | DELTEX MEDICAL LIMITED |
11440 W. BERNARDO CT. | SAN DIEGO | CA | 92127 |
| K172457 | Deltex Medical Limited |
Terminus Road | Chichester | PO19 8TX | |
| K040909 | EM-TEC GMBH |
LERCHENBERG 20 | FINNING | 86923 | |
| K111730 | EM-TEC GMBH |
LERCHENBERG 20 | FINNING | 86923 | |
| K222242 | Flosonics Medical |
325 Front St W, Floor 4 | Toronto | M5V 2Y1 | |
| K223843 | Flosonics Medical |
325 Front St W, Floor 4 | Toronto | M5V 2Y1 | |
| K191388 | Flosonics Medical (r/a 1929803 Ontario Corp.) |
204-73 Elm Street | Sudbury | P3C 1R7 | |
| K200337 | Flosonics Medical (r/a 1929803 Ontario Corp.) |
325 Front St W, Fourth Floor, OneEleven | Toronto | M5V 2Y1 | |
| K013376 | HEMEDEX INCORPORATED |
7 TIFFANY TRAIL | HOPKINTON | MA | 01748 |
| K183574 | Huntleigh Healthcare Ltd |
35 Portmanmoor Road | Cardiff | CF24 5HN | |
| K002186 | HUNTLEIGH HEALTHCARE, INC. |
40 CHRISTOPHER WAY | EATONTOWN | NJ | 07724-3327 |
| K984338 | JOSTRA BENTLEY |
478 MEDIA RD. | OXFORD | PA | 19363 |
| K010452 | KOVEN TECHNOLOGY, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071-3404 |
| K954397 | KOVEN TECHNOLOGY, INC. |
300 BROOKES DR. | ST. LOUIS | MO | 63042 |
| K201114 | Koven Technology, Inc. |
477 N. Lindbergh Blvd., Ste.220 | St. Louis | MO | 63141 |
| K031931 | KOVEN TECHNOLOGY, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071-3404 |
| K050601 | KOVEN TECHNOLOGY, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071-3404 |
| K982986 | KOVEN TECHNOLOGY, INC. |
300 BROOKES DR. | ST. LOUIS | MO | 63042 |
| K192966 | Laser Associated Sciences, Inc. |
5171 California Ave., Suite 150 | Irvine | CA | 92617 |
| K182494 | Laser Associated Sciences, Inc. |
16 Foxglove Way | Irvine | CA | 92612 |
| K040228 | MEDI-STIM A/S |
7601 NORTHLAND DRIVE | BROOKLYN PARK | MN | 55428 |
| K102595 | MEDI-STIM ASA |
435 RICE CREEK TERRACE NE | FRIDLEY | MN | 55432 |
| K973198 | MEDICARD LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K970211 | MICRO WEISS ELECTRONICS |
55 NORTHERN BLVD. SUITE 410 | GREAT NECK | NY | 11021 |
| K970139 | MICRO WEISS ELECTRONICS |
55 NORTHERN BLVD. SUITE 410 | GREAT NECK | NY | 11021 |
| K102433 | MOOR INSTRUMENTS LTD. |
MILLWEY | AXMINSTER, DEVON | EX135HU | |
| K050088 | NEOPROBE CORP. |
425 METRO PLACE NORTH, | DUBLIN | OH | 43017 |
| K040654 | OPTICAL SENSORS, INC. |
800 LENANGER LN. | STOUGHTON | WI | 53589 |
| K131854 | OR-NIM MEDICAL LTD. |
15 ATIR YEDA ST. | KFAR SABA | 4464312 | |
| K150268 | OR-NIM MEDICAL LTD. |
15 ATIR YEDA ST. | KFAR SABA | 4464312 | |
| K152930 | PERIMED AB |
DATAVAGEN 9A | JARFALLA | 17543 | |
| K011899 | PERIMED AB |
DATAVAGEN 9-A | JARFALLA | S-175 26 | |
| K974285 | PERIMED, INC. |
821 WEST JERICHO TURNPIKE | SMITHTOWN | NY | 11787 |
| K212065 | Remington Medical, Inc. |
6830 Meadowridge Court | Alpharetta | GA | 30005 |
| K211589 | Remington Medical, Inc. |
6830 Meadowridge Court | Alpharetta | GA | 30005 |
| K181269 | Rfpi |
1800 N Greene Street, Suite K | Greenville | NC | 27834 |
| K992387 | ROSSMAX INTERNATIONAL LTD. |
2F. NO. 10, ALLEY 20 LANE 106 | TAIPEI | ||
| K992388 | ROSSMAX INTERNATIONAL LTD. |
2F. NO. 10, ALLEY 20 LANE 106 | TAIPEI | ||
| K973078 | SEIN ELECTRONICS CO., LTD. |
ONE LETHBRIDGE PLAZA | MAHWAH | NJ | 07430-2113 |
| K972798 | SOMETEC, INC. |
92 MONTVALE AVE., SUITE 3150 | STONEHAM | MA | 02180 |
| K213974 | Synovis Micro Companies Alliance, Inc. |
(a Subsidiary of Baxter International Inc.) | Birmingham | AL | 35211 |
| K030505 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. | ELKTON | MD | 21921 |
| K033424 | TRANSONIC SYSTEMS, INC. |
34 DUTCH MILL RD. | ITHACA | NY | 14850 |
| K112657 | TRANSONIC SYSTEMS, INC. |
34 DUTCH MILL RD. | ITHACA | NY | 14850 |
| K140740 | TRANSONIC SYSTEMS, INC. |
34 DUTCH MILL RD. | ITHACA | NY | 14850 |
| K110438 | VASAMED, INC. |
800 LEVANGER LANE | STOUGHTON | WI | 53589 |
| K052209 | VASCULAR CONTROL SYSTEMS, INC |
32236 PASEO ADELANTO, STE. F | SAN JUAN CAPISTRANO | CA | 92675 |
| K031091 | VASCULAR TECHNOLOGY INCORPORATED |
175 CABOT ST. | LOWELL | MA | 01854 |
| K082870 | VASCULAR TECHNOLOGY INCORPORATED |
12 MURPHY DR. | NASHUA | NH | 03062 |
| K992529 | VITAL MEDICAL LTD. |
815 CONNECTICUT AVE., N.W. | WASHINGTON | DC | 20006-4004 |
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