Device Classification Name |
Cannula, Nasal, Oxygen
|
510(k) Number |
K911740 |
Device Name |
SALTER LABS NEONATAL NASAL OXYGEN CANNULA |
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 | 868.5340
|
Classification Product Code |
|
Date Received | 04/17/1991 |
Decision Date | 07/24/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|