Device Classification Name |
Calculator, Pulmonary Function Data
|
510(k) Number |
K810196 |
Device Name |
SYSTEM 84 COMPUTERIZED LUNG VOL. SPIROM |
Applicant |
CARDIO PULMONARY INSTRUMENTS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CARDIO PULMONARY INSTRUMENTS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.1880
|
Classification Product Code |
|
Date Received | 01/23/1981 |
Decision Date | 02/05/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|