Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K121927 |
Device Name |
MICROSTREAM FILTERLINE ICU |
Applicant |
ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O. BOX 45025 |
HAR HOTZVIM INDUSTRIAL PARK |
JERUSALEM,
IL
91450
|
|
Applicant Contact |
DALIA GIVONY |
Correspondent |
ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O. BOX 45025 |
HAR HOTZVIM INDUSTRIAL PARK |
JERUSALEM,
IL
91450
|
|
Correspondent Contact |
DALIA GIVONY |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 07/02/2012 |
Decision Date | 11/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|