Device Classification Name |
mouthpiece, breathing
|
510(k) Number |
K863049 |
Device Name |
INHALATION AID |
Applicant |
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. |
90 EAST RIDGE |
P.O. BOX 368 |
RIDGEFIELD,
CT
06877
|
|
Applicant Contact |
RUTH WASSERMAN |
Correspondent |
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. |
90 EAST RIDGE |
P.O. BOX 368 |
RIDGEFIELD,
CT
06877
|
|
Correspondent Contact |
RUTH WASSERMAN |
Regulation Number | 868.5620
|
Classification Product Code |
|
Date Received | 08/12/1986 |
Decision Date | 10/15/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|