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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 K911604
Device Name MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM)
Applicant
Medphone Corp.
The Atrium Suite 210 E. 80
Rte. 4
Paramus,  NJ  07652
Applicant Contact GLENN KRAPF
Correspondent
Medphone Corp.
The Atrium Suite 210 E. 80
Rte. 4
Paramus,  NJ  07652
Correspondent Contact GLENN KRAPF
Regulation Number870.5300
Classification Product Code
LDD  
Date Received04/10/1991
Decision Date 09/23/1991
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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