Cleared Traditional

PDT CARRYALL TRANSMITTER, VARIOUS MODELS

K912379 · Cardiac Pacemakers, Inc. · Cardiovascular
Jun 1991
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K912379 is an FDA 510(k) clearance for the PDT CARRYALL TRANSMITTER, VARIOUS MODELS, a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 17, 1991, 19 days after receiving the submission on May 29, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K912379 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1991
Decision Date June 17, 1991
Days to Decision 19 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DXH — Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2920

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