Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K844420 |
Device Name |
MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR |
Applicant |
MED-LIFE, INC. |
4520 WOODBEND |
BRYAN,
TX
77803
|
|
Applicant Contact |
DONALD W WELCH |
Correspondent |
MED-LIFE, INC. |
4520 WOODBEND |
BRYAN,
TX
77803
|
|
Correspondent Contact |
DONALD W WELCH |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 11/15/1984 |
Decision Date | 12/17/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|