FDA 510(k) Applications for Medical Device:
System, Hypothermia, Intravenous, Cooling
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K030421 | ALSIUS CORP. |
15770 LAGUNA CANYON, SUITE 150 | IRVINE | CA | 92618 |
| K051912 | ALSIUS CORP. |
15770 LAGUNA CANYON, SUITE 150 | IRVINE | CA | 92618 |
| K060308 | ALSIUS CORP. |
15770 LAGUNA CANYON, SUITE 150 | IRVINE | CA | 92618 |
| K014241 | ALSIUS CORP. |
15770 LAGUNA CANYON, SUITE 150 | IRVINE | CA | 92618 |
| K052443 | ALSIUS CORP. |
15770 LAGUNA CANYON, SUITE 150 | IRVINE | CA | 92618 |
| K070161 | ALSIUS CORP. |
15770 LAGUNA CANYON, SUITE 150 | IRVINE | CA | 92618 |
| K081936 | ALSIUS CORP. |
15770 LAGUNA CANYON, SUITE 150 | IRVINE | CA | 92618 |
| K063829 | ALSIUS CORP. |
15770 LAGUNA CANYON, SUITE 150 | IRVINE | CA | 92618 |
| K072234 | ALSIUS CORP. |
15770 LAGUNA CANYON RD | IRVINE | CA | 92618 |
| K022366 | INNERCOOL THERAPIES |
3931 SORRENTO VALLEY BLVD. | SAN DIEGO, | CA | 92121 |
| K033623 | INNERCOOL THERAPIES, INC. |
3931 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K080908 | INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION |
6740 TOP GUN STREET | SAN DIEGO | CA | 92121 |
| K080899 | MEDIVANCE, INC. |
1172 CENTURY DR., SUITE 240 | LOUISVILLE | CO | 80027 |
| K153162 | NOVOCOR MEDICAL SYSTEMS, INC |
2 DAVIS DRIVE | DURHAM | NC | 27709 |
| K063405 | RADIANT MEDICAL |
250 CHESAPEAKE DR. | REDWOOD CITY | CA | 94063 |
| K071008 | RADIANT MEDICAL |
250 CHESAPEAKE DR. | REDWOOD CITY | CA | 94063 |
| K071358 | RADIANT MEDICAL |
250 CHESAPEAKE DR. | REDWOOD CITY | CA | 94063 |
| K012512 | RADIANT MEDICAL |
250 CHESAPEAKE DR. | REDWOOD CITY | CA | 94063 |
| K152946 | SEIRATHERM GMBH |
BEETHOVEN STREET. 10 | 91074 HERZOGENAURACH | 13033 | |
| K101987 | ZOLL CIRCULATION |
650 ALMANOR AVENUE | SUNNYVALE | CA | 94085 |
| K141139 | ZOLL CIRCULATION |
2000 Ringwood Ave | San Jose | CA | 95131 |
| K220008 | ZOLL Circulation, Inc |
2000 Ringwood Avenue | San Jose | CA | 95131 |
| K213031 | Zoll Circulation, Inc. |
200 Ringwood Avenue | San Jose | CA | 95131 |
| K223746 | Zoll Circulation, Inc. |
2000 Ringwood Avenue | San Jose | CA | 95131 |
| K153226 | ZOLL CIRCULATION, INC. |
2000 RINGWOOD AVE. | SAN JOSE | CA | 95131 |
| K150046 | Zoll Circulation, Inc. |
2000 Ringwood Avenue | San Jose | CA | 95131 |
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