Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K883383 |
Device Name |
LIFEGUARD VENT MASK |
Applicant |
BREATH OF LIFE, INC. |
P.O. BOX 7144 |
FLUSHING,
NY
11355
|
|
Applicant Contact |
SIMPSON GRAY |
Correspondent |
BREATH OF LIFE, INC. |
P.O. BOX 7144 |
FLUSHING,
NY
11355
|
|
Correspondent Contact |
SIMPSON GRAY |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 08/09/1988 |
Decision Date | 11/21/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|