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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K950483
Device Name HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR
Applicant
Hewlett-Packard Co.
1700 S. Baker St.
Mcminnville,  OR  97128
Applicant Contact NANCY WINN
Correspondent
Hewlett-Packard Co.
1700 S. Baker St.
Mcminnville,  OR  97128
Correspondent Contact NANCY WINN
Regulation Number870.5550
Classification Product Code
DRO  
Date Received02/03/1995
Decision Date 05/22/1995
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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