Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K880394 |
Device Name |
FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR |
Applicant |
INTERTECH/OHIO |
5030 TICE ST. |
FORT MYERS,
FL
33905
|
|
Applicant Contact |
JAMES W POPE |
Correspondent |
INTERTECH/OHIO |
5030 TICE ST. |
FORT MYERS,
FL
33905
|
|
Correspondent Contact |
JAMES W POPE |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 01/29/1988 |
Decision Date | 02/29/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|