FDA 510(k) Applications for Medical Device:
System, Ecg Analysis
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K090895 | BIONET CO., LTD. |
ROOM 431, LIFEOFFICETEL | -GU, SEOUL | 150-731 | |
| K011328 | BIONET COMPANY LTD |
3F, DAEYANG BLDG., 999 | SEOUL | ||
| K023034 | BIONET COMPANY LTD |
1308 MORNINGSIDE PARK DR. | ALPHARETTA | GA | 30022 |
| K973922 | BIOSOUND ESAOTE, INC. |
8000 CASTLEWAY DR. | INDIANAPOLIS | IN | 46250 |
| K946281 | BURDICK, INC. |
15 PLUMB ST. | MILTON | WI | 53563-1499 |
| K962854 | CARDIO CONTROL BV |
1870 THE EXCHANGE | ATLANTA | GA | 30339 |
| K961223 | CRITICARE SYSTEMS, INC. |
20925 CROSSROADS CIRCLE | WAUKESHA | WI | 53186 |
| K972587 | DR. LEE CO., LTD. |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K984465 | ERICH JAEGER B.V. |
REGULIERENING 11 | NL-3981 LA BUNNIK | NL-3981 | |
| K971440 | FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C | REDMOND | WA | 98052-4911 |
| K981066 | FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C | REDMOND | WA | 98052-4911 |
| K991014 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K991735 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K951978 | HEWLETT-PACKARD CO. |
1700 SOUTH BAKER ST. | MCMINNVILLE | OR | 97128 |
| K974087 | HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1085 |
| K954980 | HEWLETT-PACKARD CO. |
1700 SOUTH BAKER ST. | MCMINNVILLE | OR | 97128 |
| K981265 | HEWLETT-PACKARD CO. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K951130 | MARQUETTE ELECTRONICS, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K964750 | MARQUETTE ELECTRONICS, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K974199 | MARQUETTE MEDICAL SYSTEMS, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K973403 | MARQUETTE MEDICAL SYSTEMS, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K980495 | MARQUETTE MEDICAL SYSTEMS, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K981024 | MARQUETTE MEDICAL SYSTEMS, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K990266 | MICROMEDICAL INDUSTRIES, LTD. |
189 HAPP RD. | NORTHFIELD | IL | 60093 |
| K974352 | MICROMEDICAL, INC. |
255 REVERE DR., SUITE 111 | NORTHBROOK | IL | 60062 |
| K993616 | NASIFF ASSOC., INC. |
9422 LEBEAU LN. | BREWERTON | NY | 13029 |
| K990031 | NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. | IRVINE | CA | 92612-1601 |
| K984504 | NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. | IRVINE | CA | 92612-1601 |
| K961272 | NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. | IRVINE | CA | 92612-1601 |
| K073376 | PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1099 |
| K972255 | PULSE BIOMEDICAL, INC. |
935 SOUTH TROOPER RD. | NORRISTOWN | PA | 19403 |
| K083749 | QRS DIAGNOSTIC, LLC. |
14755 27TH AVE.NORTH | PLYMOUTH | MN | 55447 |
| K961014 | QUINTON, INC. |
3303 MONTE VILLA PKWY. | BOTHELL | WA | 98021-8906 |
| K970879 | SCHILLER AMERICA, INC. |
3002 DOW AVE., #138 | TUSTIN | CA | 92780 |
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