Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K002163 |
Device Name |
MICROSTREAM EXTERNAL BATTERY CHARGER |
Applicant |
ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O.B. 45025 |
HAR HOTZVIM INDUSTRIAL PARK |
JERUSALEM,
IL
91450
|
|
Applicant Contact |
SANFORD BROWN |
Correspondent |
ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O.B. 45025 |
HAR HOTZVIM INDUSTRIAL PARK |
JERUSALEM,
IL
91450
|
|
Correspondent Contact |
SANFORD BROWN |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 07/18/2000 |
Decision Date | 01/11/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|