Device Classification Name |
nebulizer, medicinal, non-ventilatory (atomizer)
|
510(k) Number |
K870755 |
Device Name |
CHALLENGER DOSIMETER |
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 | 02/26/1987 |
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
|
|
|