FDA 510(k) Applications for Medical Device:
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K223857 | ABBOTT POINT OF CARE, INC |
400 College Road East | Princeton | NJ | 08540 |
| K200492 | Abbott point of Care, Inc. |
400 College Road East | Princeton | NJ | 08540 |
| K963964 | AVL SCIENTIFIC CORP. |
33 MANSELL COURT | ROSWELL | GA | 30076-4807 |
| K990092 | AVL SCIENTIFIC CORP. |
33 MANSELL COURT | ROSWELL | GA | 30076-4807 |
| K961161 | AVL SCIENTIFIC CORP. |
33 MANSELL COURT | ROSWELL | GA | 30076-4807 |
| K000103 | AVL SCIENTIFIC CORP. |
235 HEMBREE PARK DR. | ROSWELL | GA | 30076 |
| K002738 | BAYER CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052-1688 |
| K031560 | BAYER HEALTHCARE, LLC |
63 NORTH ST. | MEDFIELD | MA | 02052-1688 |
| K962021 | CIBA CORNING DIAGNOSTICS CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052-1688 |
| K961657 | CIBA CORNING DIAGNOSTICS CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052-1688 |
| K980523 | DIAMETRICS MEDICAL, INC. |
2658 PATTON RD. | SAINT PAUL | MN | 55113 |
| K974396 | DIAMETRICS MEDICAL, INC. |
2658 PATTON RD. | SAINT PAUL | MN | 55113 |
| K151978 | EDAN INSTRUMENTS, INC. |
3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK, #1019 NANHAI ROAD | SHENZHEN | 518067 | |
| K200107 | Epocal Inc. |
2060 Walkley Road | Ottawa | K1G 3P5 | |
| K993789 | GENERAL AIR SERVICE AND SUPPLY |
6330 COLORADO BLVD. | COMMERCE CITY | CO | 80022 |
| K012478 | I-STAT CORP. |
104 WINDSOR CENTER DR. | EAST WINDSOR | NJ | 08520 |
| K992834 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K133407 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K061974 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K173403 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K203790 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K160412 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K955793 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K963800 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K223608 | Instrumentation Laboratory Company |
180 Hartwell Road | Bedford | MA | 01730 |
| K961335 | MALLINCKRODT SENSOR SYSTEMS, INC. |
1590 EISENHOWER PL. | ANN ARBOR | MI | 48108 |
| K974526 | MEDICA CORP. |
14 DEANGELO DR. | BEDFORD | MA | 01730 |
| K021515 | MEDICA CORP. |
14 DEANGELO DR. | BEDFORD | MA | 01730 |
| K063376 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K211559 | Medica Corporation |
5 Oak Park Drive | Bedford | MA | 01730 |
| K982277 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K002613 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K980991 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K020297 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K022746 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K014295 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K013729 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K021713 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K012058 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K023567 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K970710 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K110648 | NOVA BIOMEDICAL CORPORATION |
200 PROSPECT ST. | WALTHAM | MA | 02453 |
| K131703 | NOVA BIOMEDICAL CORPORATION |
200 Prospect St | WALTHAM | MA | 02454 |
| K151982 | NOVA BIOMEDICAL CORPORATION |
200 PROSPECT ST. | WALTHAM | MA | 02454 |
| K142220 | NOVA BIOMEDICAL CORPORATION |
200 PROSPECT ST. | WALTHAM | MA | 02454 |
| K141907 | NOVA BIOMEDICAL CORPORATION |
200 Prospect St | WALTHAM | MA | 02454 |
| K173797 | Nova Biomedical Corporation |
200 Prospect St. | Waltham | MA | 02454 |
| K221900 | Nova Biomedical Corporation |
200 Prospect St. | Waltham | MA | 02454 |
| K193246 | Nova Biomedical Corporation |
200 Prospect Street | Waltham | MA | 02454 |
| K093280 | OPTI MEDICAL SYSTEMS INC. |
235 HEMBREE PARK DRIVE | ROSWELL | GA | 30076 |
| K131126 | OPTI MEDICAL SYSTEMS INC. |
235 Hembree Park Dr | ROSWELL | GA | 30076 |
| K200986 | OPTI Medical Systems, Inc. |
235 Hembree Park Drive | Roswell | GA | 30114 |
| K991417 | RADIOMETER AMERICA, INC. |
810 SHARON DR. | WESTLAKE | OH | 44145-1598 |
| K973367 | RADIOMETER AMERICA, INC. |
810 SHARON DR. | WESTLAKE | OH | 44145-1598 |
| K992859 | RADIOMETER AMERICA, INC. |
810 SHARON DR. | WESTLAKE | OH | 44145-1598 |
| K980130 | RADIOMETER AMERICA, INC. |
810 SHARON DR. | WESTLAKE | OH | 44145-1598 |
| K982928 | RADIOMETER AMERICA, INC. |
810 SHARON DR. | WESTLAKE | OH | 44145-1598 |
| K002290 | RADIOMETER MEDICAL A/S |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 | |
| K041874 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 | |
| K043218 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 | |
| K110416 | RADIOMETER MEDICAL APS |
AAKANDEVEJ 21 | BROENSHOEJY | DK-2700 | |
| K100777 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 | |
| K111897 | RADIOMETER MEDICAL APS |
AAKANDEVEJ 21 | COPENHAGEN | 2100 | |
| K120197 | RADIOMETER MEDICAL APS |
AAKANDEVEJ 21 | BRONSHOJ | DK-2700 | |
| K122642 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 | |
| K122729 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 | |
| K123748 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 | |
| K130144 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 | |
| K131988 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 | |
| K160153 | RADIOMETER MEDICAL APS |
AAKANDEVEJ 21 | BROENSHOEJ | DK-2700 | |
| K142898 | Radiometer Medical Aps. |
Aakandevej 21 | Broenshoej | 2700 | |
| K111188 | Roche Diagnostics |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K050423 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K151856 | SENDX MEDICAL INC. |
1945 PALOMAR OAKS WAY | CARLSBAD | CA | 92011 |
| K994346 | SENDX MEDICAL, INC. |
1945 PALOMAR OAKS WAY | CARLSBAD | CA | 92011 |
| K080370 | SENDX MEDICAL, INC. |
1945 PALOMAR OAKS WAY | CARLSBAD | CA | 92011 |
| K051804 | SENDX MEDICAL, INC. |
1945 PALOMAR OAKS WAY | CARLSBAD | CA | 92011 |
| K122539 | SIEMENS HEALTHCARE DIAGNOSTICS |
2 EDGEWATER DRIVE | NORWOOD | MA | 02062 |
| K192240 | Siemens Healthcare Diagnostics, Inc. |
2 Edgewater Drive | Norwood | MA | 02062 |
| K984384 | THERMO BIOANALYSIS CORP. |
333 FISKE ST. | HOLLISTON | MA | 01746 |
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