Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K952169 |
Device Name |
SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC |
Applicant |
INTERTECH RESOURCES, INC. |
5100 TICE ST. |
FT. MYERS,
FL
33905
|
|
Applicant Contact |
AVIA TONEY |
Correspondent |
INTERTECH RESOURCES, INC. |
5100 TICE ST. |
FT. MYERS,
FL
33905
|
|
Correspondent Contact |
AVIA TONEY |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 05/08/1995 |
Decision Date | 06/08/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|