FDA 510(k) Applications for Medical Device:
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K002061 | A & D ENGINEERING, INC. |
1555 MC CANDLESS DR. | MILPITAS | CA | 95035 |
| K010587 | ACTIVE CORP. |
15 MAIN ST. | CASTINE | ME | 04421-1000 |
| K972789 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K972787 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K234003 | Circadia Technologies, Ltd. |
20 St Thomas Street | London | SE1 9RS | |
| K051038 | CIRITICARE SYSTEMS, INC. |
20925 CROSSROADS CIRCLE | WAUKESHA | WI | 53186 |
| K012763 | COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY | ARVADA | CO | 80004 |
| K181165 | Connected Sensing- A Division of Philips Medical Systems |
2 Canal Park | Cambridge | MA | 02141 |
| K091050 | CRITICARE SYSTEMS, INC. |
20925 CROSSROADS CIRCLE | WAUKESHA | WI | 53186 |
| K022435 | CRITICARE SYSTEMS, INC. |
20925 CROSSROADS CIRCLE | WAUKESHA | WI | 53186 |
| K974178 | DATASCOPE CORP. |
580 WINTERS AVE. | PARAMUS | NJ | 07653 |
| K981378 | DATEX-ENGSTROM, INC. |
3 HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
| K030656 | ENVAN, LLC |
719 A STREET, NE | WASHINGTON | DC | 20002 |
| K121860 | FLUKE BIOMEDICAL |
6045 COCHRAN RD. | SOLON | OH | 44139 |
| K121722 | FLUKE BIOMEDICAL |
6045 COCHRAN RD. | SOLON | OH | 44139 |
| K103336 | FLUKE BIOMEDICAL |
6045 COCHRAN RD. | SOLON | OH | 44139 |
| K110429 | FLUKE BIOMEDICAL |
6045 COCHRAN RD. | SOLON | OH | 44139 |
| K060307 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K033646 | HEALTHFIRST CORP. |
13170-B CENTRAL AVE SE | ALBUQUERQUE | NM | 87123 |
| K052446 | HOANA MEDICAL, INC. |
1001 BISHOP STREET, STE 2828 | HONOLULU | HI | 96813 |
| K100745 | HOANA MEDICAL, INC. |
21031 SE 202ND STREET | RENTON | WA | 98058 |
| K083534 | HOANA MEDICAL, INC. |
828 FORT STREET MALL | HONOLULU | HI | 96825 |
| K082366 | HOANA MEDICAL, INC. |
828 FORT STREET MALL | HONOLULU | HI | 96825 |
| K092037 | HOANA MEDICAL, INC. |
21031 SE 202ND STREET | RENTON | WA | 98058 |
| K974581 | INVIVO RESEARCH, INC. |
12601 RESEARCH PKWY. | ORLANDO | FL | 32826 |
| K043354 | INVIVO RESEARCH, INC. |
12601 RESEARCH PKWY. | ORLANDO | FL | 32826 |
| K151781 | IVY BIOMEDICAL SYSTEMS INC. |
11 BUSINESS PARK DRIVE | BRANFORD | CT | 06405 |
| K110987 | IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. | BRANFORD | CT | 06405 |
| K170828 | Ivy Biomedical Systems, Inc. |
11 Business Park Drive | Branford | CT | 06405 |
| K202138 | Ivy Biomedical Systems, Inc. |
11 Business Park Drive | Branford | CT | 06405 |
| K083854 | IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. | BRANFORD | CT | 06405 |
| K023616 | IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. | BRANFORD | CT | 06405 |
| K091985 | IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. | BRANFORD | CT | 06405 |
| K992413 | MEDICAL DATA ELECTRONICS |
12720 WENTWORTH ST. | ARLETA | CA | 91331 |
| K992411 | MEDICAL DATA ELECTRONICS |
12720 WENTWORTH ST. | ARLETA | CA | 91331 |
| K232354 | Murata Vios, Inc. |
700 Commerce Drive, #190 | Woodbury | MN | 55125 |
| K965158 | N.P.N.T., INC. |
111 MARTIN ROSS AVENUE, | DOWNSVIEW, ONTARIO | M3J-2M7 | |
| K960544 | NASIFF ASSOC., INC. |
9422 LEBEAU LN. | BREWERTON | NY | 13029 |
| K231733 | Neteera Technologies Ltd. |
Prof Rakah 3 St. | Jerusalem | 9139002 | |
| K212143 | Neteera Technologies Ltd. |
Hebrew University Givat Ram Campus, | Jerusalem | 9518702 | |
| K952790 | NIAN-CRAE, INC. |
13 CORTLAND DR. | SOMERSET | NJ | 08873 |
| K973918 | NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. | IRVINE | CA | 92612-1601 |
| K043517 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K063735 | PRESYM, INC. |
15 TWELVE OAKS DRIVE | PLEASANTON | CA | 94588 |
| K002725 | PROTOCOL SYSTEMS, INC. |
8500 S.W. CREEKSIDE PLACE | BEAVERTON | OR | 97008-7101 |
| K950688 | SAFETY TEK CORP. |
12601 RESEARCH PKWY. | ORLANDO | FL | 32826 |
| K963576 | SCIENTIFIC APPLICATIONS |
4224 CAMPUS POINT COURT | SAN DIEGO | CA | 92121-2211 |
| K032733 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
55 NORTHERN BLVD., SUITE 200 | GREAT NECK | NY | 11021 |
| K020144 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K223163 | Sleepiz AG |
Hornbachstrasse 23 | Zurich | 8008 | |
| K150992 | VIOS MEDICAL, INC. |
7300 HUDSON BLVD N, STE 140 | ST. PAUL | MN | 55128 |
| K172586 | Vios Medical, Inc. |
7300 Hudson Blvd N | St. Paul | MN | 55128 |
| K021681 | WELCH ALLYN PROTOCOL, INC. |
8500 S.W. CREEKSIDE PLACE | BEAVERTON | OR | 97008-7107 |
| K012451 | WELCH ALLYN PROTOCOL, INC. |
8500 S.W. CREEKSIDE PLACE | BEAVERTON | OR | 97008-7107 |
| K984033 | WELCH ALLYN, INC. |
4341 STATE ST. RD. | SKANEATELES FALLS | NY | 13153-0220 |
| K082626 | WIRELESS 2000 RF & UWB TECHNOLOGIES LTD. |
2421 ALPHA AVE | BURNABY, BC | V5C5L2 | |
| K092809 | WR MEDICAL ELECTRONICS CO. |
800 LAVANGER LANE | STOUGHTON | WI | 53589 |
| K202464 | Xandar Kardian Inc. |
#309, Seongsuil-Ro 10-Gil Seongdong-gu | Seoul | 04793 | |
| K001775 | ZOE MEDICAL, INC. |
460 BOSTON ST. | TOPSFIELD | MA | 01983-1223 |
| K102174 | ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
269 MILL ROAD | CHELMSFORD | MA | 01824-4105 |
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