Device Classification Name |
calculator, predicted values, pulmonary function
|
510(k) Number |
K821712 |
Device Name |
INFORMED REMOTE FIELD UNIT MODEL IFM1000 |
Applicant |
BURDITT & CALKINS-SIEMENS-ELEMA |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BURDITT & CALKINS-SIEMENS-ELEMA |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 06/09/1982 |
Decision Date | 07/26/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|