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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 K914458
Device Name ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION
Applicant
Medical Data Electronics
12720 Wentworth St.
Arleta,  CA  91331
Applicant Contact CHIP HARLOW
Correspondent
Medical Data Electronics
12720 Wentworth St.
Arleta,  CA  91331
Correspondent Contact CHIP HARLOW
Regulation Number870.5300
Classification Product Code
LDD  
Date Received10/07/1991
Decision Date 12/09/1991
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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