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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated external defibrillators (non-wearable)
510(k) Number K001725
Device Name HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
Applicant
AGILENT TECHNOLOGIES, INC.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Applicant Contact RICHARD J PETERSEN
Correspondent
AGILENT TECHNOLOGIES, INC.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Correspondent Contact RICHARD J PETERSEN
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
DQA   DRO   LDD  
Date Received06/06/2000
Decision Date 09/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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