Device Classification Name |
Ph Rate Measurement, Carbon-Dioxide
|
510(k) Number |
K963005 |
Device Name |
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) |
Applicant |
NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. |
WALTHAM,
MA
02454 -9141
|
|
Applicant Contact |
PAUL W MAC DONALD |
Correspondent |
NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. |
WALTHAM,
MA
02454 -9141
|
|
Correspondent Contact |
PAUL W MAC DONALD |
Regulation Number | 862.1160
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/02/1996 |
Decision Date | 08/23/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|