Device Classification Name |
Oximeter
|
510(k) Number |
K072295 |
Device Name |
CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE |
Applicant |
ORIDION CAPNOGRAPHY, INC. |
HAMARPE 7 |
JERUSALEM,
IL
91450
|
|
Applicant Contact |
RACHEL WEISSBROD |
Correspondent |
ORIDION CAPNOGRAPHY, INC. |
HAMARPE 7 |
JERUSALEM,
IL
91450
|
|
Correspondent Contact |
RACHEL WEISSBROD |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/16/2007 |
Decision Date | 10/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|