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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K002459
Device Name PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
Applicant
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact ROB BUTLER
Correspondent
Agilent Technologies, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact ROB BUTLER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/10/2000
Decision Date 11/08/2000
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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