Cleared Traditional

PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH

K002459 · Agilent Technologies, Inc. · Cardiovascular
Nov 2000
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K002459 is an FDA 510(k) clearance for the PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on November 8, 2000, 90 days after receiving the submission on August 10, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K002459 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2000
Decision Date November 08, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340