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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K921666
Device Name CARDIAC THERAPHY SYSTEM SCP 900
Applicant
Ppg Hellige B.V.
P.O. Box 15955
Lenexa,  KS  66285
Applicant Contact GREG WHITNEY
Correspondent
Ppg Hellige B.V.
P.O. Box 15955
Lenexa,  KS  66285
Correspondent Contact GREG WHITNEY
Regulation Number870.5300
Classification Product Code
LDD  
Date Received04/07/1992
Decision Date 09/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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