HEART SYNC PEDIATRIC, MODEL PED-100


Device Classification Name

dc-defibrillator, low-energy, (including paddles)

510(k) Number K081442
Device Name HEART SYNC PEDIATRIC, MODEL PED-100
Applicant
HEART SYNC LLC
5643 plymouth road
ann arbor, 
MI 
48105

Applicant Contact stephen shulman
Correspondent
HEART SYNC LLC
5643 plymouth road
ann arbor, 
MI 
48105

Correspodent Contact stephen shulman
Regulation Number 870.5300
Classification Product Code
LDD  
Date Received 05/22/2008
Decision Date 09/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No