Device Classification Name |
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
|
510(k) Number |
K141907 |
Device Name |
STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A |
Applicant |
NOVA BIOMEDICAL CORPORATION |
200 Prospect St |
WALTHAM,
MA
02454
|
|
Applicant Contact |
PAUL W MACDONALD |
Correspondent |
NOVA BIOMEDICAL CORPORATION |
200 Prospect St |
WALTHAM,
MA
02454
|
|
Correspondent Contact |
PAUL W MACDONALD |
Regulation Number | 862.1120
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/15/2014 |
Decision Date | 05/29/2015 |
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
|
|
|