Device Classification Name |
Calculator, Predicted Values, Pulmonary Function
|
510(k) Number |
K803053 |
Device Name |
APEXLINE OF PULMONARY FUNCT. INSTRUM. |
Applicant |
WARREN E. COLLINS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
WARREN E. COLLINS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 12/02/1980 |
Decision Date | 12/22/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|