Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K930559 |
Device Name |
VITALMAX 800-C |
Applicant |
PACE TECH, INC. |
510 GARDEN AVE. NORTH |
CLEARWATER,
FL
33755
|
|
Applicant Contact |
MARY J BILGUTAY |
Correspondent |
PACE TECH, INC. |
510 GARDEN AVE. NORTH |
CLEARWATER,
FL
33755
|
|
Correspondent Contact |
MARY J BILGUTAY |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 02/03/1993 |
Decision Date | 09/03/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|