Device Classification Name |
calculator, predicted values, pulmonary function
|
510(k) Number |
K932278 |
Device Name |
PFM PROFESSIONAL 7000 SPIROMETER |
Applicant |
ADVANCED MEDICAL SYSTEMS, INC. |
C/O C. G. BUNDY ASSOCIATES |
6470 RIVERVIEW TERRACE |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
CONSTANCE G BUNDY |
Correspondent |
ADVANCED MEDICAL SYSTEMS, INC. |
C/O C. G. BUNDY ASSOCIATES |
6470 RIVERVIEW TERRACE |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
CONSTANCE G BUNDY |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 05/12/1993 |
Decision Date | 12/17/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|