Cleared Traditional

MODEL 5600B PROGRAMMER, PACEMAKER

K871986 · Telectronics, Inc. · Cardiovascular
Jun 1987
Decision
33d
Days
Class 3
Risk

About This 510(k) Submission

K871986 is an FDA 510(k) clearance for the MODEL 5600B PROGRAMMER, PACEMAKER, a Programmer, Pacemaker (Class III — Premarket Approval, product code KRG), submitted by Telectronics, Inc. (Suffield, US). The FDA issued a Cleared decision on June 24, 1987, 33 days after receiving the submission on May 22, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3700.

Submission Details

510(k) Number K871986 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1987
Decision Date June 24, 1987
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code KRG — Programmer, Pacemaker
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3700

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