Device Classification Name |
spirometer, therapeutic (incentive)
|
510(k) Number |
K873540 |
Device Name |
AEROBICA - LUNG EXERCISER |
Applicant |
MBA HEALTHCARE PRODUCTS, INC. |
519 E. GENESEE ST. |
P.O. BOX 617 |
FAYETTEVILLE,
NY
13066
|
|
Applicant Contact |
STUART A BRUCE |
Correspondent |
MBA HEALTHCARE PRODUCTS, INC. |
519 E. GENESEE ST. |
P.O. BOX 617 |
FAYETTEVILLE,
NY
13066
|
|
Correspondent Contact |
STUART A BRUCE |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 09/01/1987 |
Decision Date | 02/04/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|