Device Classification Name |
nebulizer, medicinal, non-ventilatory (atomizer)
|
510(k) Number |
K781394 |
Device Name |
DISPOSABLE INCENTIVE SPIROMETER |
Applicant |
INHAL-O-TECH MEDICAL PLASTIC |
P.O. Box 385 |
Blue Spring,
MO
64015
|
|
Applicant Contact |
Joseph W Brown |
Correspondent |
INHAL-O-TECH MEDICAL PLASTIC |
P.O. Box 385 |
Blue Spring,
MO
64015
|
|
Correspondent Contact |
Joseph W Brown |
Regulation Number | 868.5640
|
Classification Product Code |
|
Date Received | 08/14/1978 |
Decision Date | 10/16/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|