Device Classification Name |
calculator, predicted values, pulmonary function
|
510(k) Number |
K993641 |
Device Name |
METALYZER, MODEL 2; METALYZER, MODEL 3 |
Applicant |
CORTEX BIOPHYSIK GMBH |
962 ALLEGRO LN. |
APOLLO BEACH,
FL
33572
|
|
Applicant Contact |
ART WARD |
Correspondent |
CORTEX BIOPHYSIK GMBH |
962 ALLEGRO LN. |
APOLLO BEACH,
FL
33572
|
|
Correspondent Contact |
ART WARD |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 10/28/1999 |
Decision Date | 12/14/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|