Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K852096 |
Device Name |
RESUS-AID DISPOSABLE RESUSCITATION SHIELD |
Applicant |
EMERGENCY SITUATION PRODUCTS |
3240 ADEN ST. |
MEMPHIS,
TN
38127
|
|
Applicant Contact |
ROBERT T SPALDING |
Correspondent |
EMERGENCY SITUATION PRODUCTS |
3240 ADEN ST. |
MEMPHIS,
TN
38127
|
|
Correspondent Contact |
ROBERT T SPALDING |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 05/14/1985 |
Decision Date | 07/08/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|