|
Device |
system, hypothermia, intravenous, cooling |
Product Code | NCX |
Regulation Number |
870.5900
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
NOVOCOR MEDICAL SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEIRATHERM GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZOLL CIRCULATION |
|
SE - WITH LIMITATIONS
|
1
|
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K150046 Start-Up Kit (SUK), Cool Line Intravascular Heat E ...
|
2. K153226 Solex 7 Intravascular Heat Exchange Catheter, ZOLL ...
|
3. K213031 Solex 7 Intravascular Heat Exchange Catheter, Cool ...
|
4. K223746 Solex 7 Intravascular Heat Exchange Catheter, Cool ...
|
ZOLL CIRCULATION, INC |
|
SE - WITH LIMITATIONS
|
1
|
1. K150046 Start-Up Kit (SUK), Cool Line Intravascular Heat E ...
|
2. K153226 Solex 7 Intravascular Heat Exchange Catheter, ZOLL ...
|
3. K213031 Solex 7 Intravascular Heat Exchange Catheter, Cool ...
|
4. K223746 Solex 7 Intravascular Heat Exchange Catheter, Cool ...
|
ZOLL CIRCULATION, INC. |
|
SE - WITH LIMITATIONS
|
4
|
1. K150046 Start-Up Kit (SUK), Cool Line Intravascular Heat E ...
|
2. K153226 Solex 7 Intravascular Heat Exchange Catheter, ZOLL ...
|
3. K213031 Solex 7 Intravascular Heat Exchange Catheter, Cool ...
|
4. K223746 Solex 7 Intravascular Heat Exchange Catheter, Cool ...
|
|
|
|
|