Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K891672 |
Device Name |
PUL-TRON 100K PROFESSIONAL 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 | 868.1840
|
Classification Product Code |
|
Date Received | 03/21/1989 |
Decision Date | 06/16/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|