Cleared Traditional

M1765A ECG MANAGER

K974746 · Hewlett-Packard Co. · Cardiovascular
Mar 1998
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K974746 is an FDA 510(k) clearance for the M1765A ECG MANAGER, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Hewlett-Packard Co. (North Attleboro, US). The FDA issued a Cleared decision on March 18, 1998, 89 days after receiving the submission on December 19, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K974746 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 1997
Decision Date March 18, 1998
Days to Decision 89 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

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