Device Classification Name |
electrode measurement, blood-gases (pco2, po2) and blood ph
|
510(k) Number |
K013729 |
Device Name |
STAT PROFILE PHOX BASIC ANALYZER |
Applicant |
NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. |
WALTHAM,
MA
02454 -9141
|
|
Applicant Contact |
PAUL W MACDONALD |
Correspondent |
NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. |
WALTHAM,
MA
02454 -9141
|
|
Correspondent Contact |
PAUL W MACDONALD |
Regulation Number | 862.1120
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/09/2001 |
Decision Date | 01/15/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|