Device Classification Name |
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
|
510(k) Number |
K122539 |
Device Name |
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS |
2 EDGEWATER DRIVE |
NORWOOD,
MA
02062
|
|
Applicant Contact |
Steven Goldberg |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS |
2 EDGEWATER DRIVE |
NORWOOD,
MA
02062
|
|
Correspondent Contact |
Steven Goldberg |
Regulation Number | 862.1120
|
Classification Product Code |
|
Date Received | 08/21/2012 |
Decision Date | 04/19/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|