Device Classification Name |
analyzer, gas, helium, gaseous-phase
|
510(k) Number |
K903939 |
Device Name |
PANDA HELIUM GAS ANALYZER |
Applicant |
MEDICAL ASSOCIATED SERVICES, INC. |
P.O. BOX 530 |
HATFIELD,
PA
19440
|
|
Applicant Contact |
MARK S ALSBERGE |
Correspondent |
MEDICAL ASSOCIATED SERVICES, INC. |
P.O. BOX 530 |
HATFIELD,
PA
19440
|
|
Correspondent Contact |
MARK S ALSBERGE |
Regulation Number | 868.1640
|
Classification Product Code |
|
Date Received | 08/27/1990 |
Decision Date | 01/03/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|