ONESTEP PEDIATRIC MFE’S


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K110978
Device Name ONESTEP PEDIATRIC MFE’S
Applicant
ZOLL MEDICAL CORPORATION
525 narragansett park drive
pawtucket, 
RI 
02861

Applicant Contact robert morse
Correspondent
ZOLL MEDICAL CORPORATION
525 narragansett park drive
pawtucket, 
RI 
02861

Correspodent Contact robert morse
Regulation Number 870.5310
Classification Product Code
MKJ  
Date Received 04/07/2011
Decision Date 05/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No