510(k) K002459

PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH by Agilent Technologies, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2000
Date Received
August 10, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type