Device Classification Name |
mask, oxygen
|
510(k) Number |
K945472 |
Device Name |
WESTMED PEDIATRIC AND ADULT AEROSOL MASK |
Applicant |
WESTMED INTL. |
3351 EAST HEMISPHERE LOOP |
TUCSON,
AZ
85706
|
|
Applicant Contact |
LYNN HAYSE |
Correspondent |
WESTMED INTL. |
3351 EAST HEMISPHERE LOOP |
TUCSON,
AZ
85706
|
|
Correspondent Contact |
LYNN HAYSE |
Regulation Number | 868.5580
|
Classification Product Code |
|
Date Received | 11/08/1994 |
Decision Date | 02/07/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|