Cleared Traditional

DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER

K903437 · Keller Medical Specialties Products, Inc. · Cardiovascular
Nov 1990
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K903437 is an FDA 510(k) clearance for the DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER, a Pacemaker, Cardiac, External Transcutaneous (non-invasive) (Class II — Special Controls, product code DRO), submitted by Keller Medical Specialties Products, Inc. (Antioch, US). The FDA issued a Cleared decision on November 16, 1990, 108 days after receiving the submission on July 31, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5550.

Submission Details

510(k) Number K903437 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1990
Decision Date November 16, 1990
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

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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