Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K093388 |
Device Name |
SMART CAPNOLINE GUARDIAN |
Applicant |
ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O.B. 45025 |
HAR HOTZVIM INDUSTRIAL PARK |
JERUSALEM,
IL
91450
|
|
Applicant Contact |
RACHEL WEISSBROD |
Correspondent |
ORIDION MEDICAL 1987 LTD. |
7 HAMARPE ST. P.O.B. 45025 |
HAR HOTZVIM INDUSTRIAL PARK |
JERUSALEM,
IL
91450
|
|
Correspondent Contact |
RACHEL WEISSBROD |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 10/30/2009 |
Decision Date | 03/04/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|