Device Classification Name |
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
|
510(k) Number |
K131703 |
Device Name |
NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM |
Applicant |
NOVA BIOMEDICAL CORPORATION |
200 Prospect St |
WALTHAM,
MA
02454
|
|
Applicant Contact |
PAUL W MCDONALD |
Correspondent |
NOVA BIOMEDICAL CORPORATION |
200 Prospect St |
WALTHAM,
MA
02454
|
|
Correspondent Contact |
PAUL W MCDONALD |
Regulation Number | 862.1120
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/11/2013 |
Decision Date | 03/25/2014 |
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
|
Recalls |
CDRH Recalls
|