Device Classification Name |
Calculator, Pulmonary Function Interpretor (Diagnostic)
|
510(k) Number |
K911143 |
Device Name |
PB100 DIAGNOSTIC SPIROMETER |
Applicant |
PURITAN BENNETT CORP. |
9401 INDIAN CREEK PKWY. |
P.O. BOX 25905 |
OVERLAND PARK,
KS
66225
|
|
Applicant Contact |
TIMOTHY D SAMSEL |
Correspondent |
PURITAN BENNETT CORP. |
9401 INDIAN CREEK PKWY. |
P.O. BOX 25905 |
OVERLAND PARK,
KS
66225
|
|
Correspondent Contact |
TIMOTHY D SAMSEL |
Regulation Number | 868.1900
|
Classification Product Code |
|
Date Received | 03/14/1991 |
Decision Date | 11/29/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|