Device Classification Name |
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
|
510(k) Number |
K870027 |
Device Name |
HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER |
Applicant |
SALTER LABS |
P.O. BOX 608 |
ARVIN,
CA
93203
|
|
Applicant Contact |
JAMES N CURTI |
Correspondent |
SALTER LABS |
P.O. BOX 608 |
ARVIN,
CA
93203
|
|
Correspondent Contact |
JAMES N CURTI |
Regulation Number | 868.5640
|
Classification Product Code |
|
Date Received | 01/05/1987 |
Decision Date | 03/16/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|