Cleared Traditional

M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION

K974420 · Hewlett-Packard Co. · Cardiovascular
Feb 1998
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K974420 is an FDA 510(k) clearance for the M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION, a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Hewlett-Packard Co. (North Attleboro, US). The FDA issued a Cleared decision on February 19, 1998, 87 days after receiving the submission on November 24, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K974420 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1997
Decision Date February 19, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSH — Recorder, Magnetic Tape, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800

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