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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 K844740
Device Name MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT
Applicant
Hewlett-Packard Co.
1700 S. Baker St.
Mcminnville,  OR  97128
Applicant Contact RICHARD W STRAYER
Correspondent
Hewlett-Packard Co.
1700 S. Baker St.
Mcminnville,  OR  97128
Correspondent Contact RICHARD W STRAYER
Regulation Number870.5300
Classification Product Code
LDD  
Date Received12/05/1984
Decision Date 02/12/1985
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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