Cleared Traditional

CARDIOSERV P

K962547 · Marquette Electronics, Inc. · Cardiovascular
Mar 1997
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K962547 is an FDA 510(k) clearance for the CARDIOSERV P, a Pacemaker, Cardiac, External Transcutaneous (non-invasive) (Class II — Special Controls, product code DRO), submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on March 6, 1997, 251 days after receiving the submission on June 28, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5550.

Submission Details

510(k) Number K962547 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 1996
Decision Date March 06, 1997
Days to Decision 251 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRO — Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5550

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