Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K852062 |
Device Name |
SARACAP RESPIRATORY MONITOR |
Applicant |
ALLEGHANY INTL. MEDICAL TECHNOLOGY |
897 FEE FEE RD. |
ST.LOUIS,
MO
63043
|
|
Applicant Contact |
MICHAEL LOMBARDO |
Correspondent |
ALLEGHANY INTL. MEDICAL TECHNOLOGY |
897 FEE FEE RD. |
ST.LOUIS,
MO
63043
|
|
Correspondent Contact |
MICHAEL LOMBARDO |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 05/09/1985 |
Decision Date | 08/06/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|