Device Classification Name |
Mask, Oxygen
|
510(k) Number |
K790166 |
Device Name |
OXYGEN MASK, ADULT VINYL |
Applicant |
AIRLIFE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AIRLIFE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5580
|
Classification Product Code |
|
Date Received | 01/12/1979 |
Decision Date | 03/16/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|