Cleared Traditional

MODEL 1740 PERSONAL POCKET PROGRAMMER

K864712 · Telectronics, Inc. · Cardiovascular
Dec 1987
Decision
379d
Days
Class 3
Risk

About This 510(k) Submission

K864712 is an FDA 510(k) clearance for the MODEL 1740 PERSONAL POCKET PROGRAMMER, a Programmer, Pacemaker (Class III — Premarket Approval, product code KRG), submitted by Telectronics, Inc. (Suffield, US). The FDA issued a Cleared decision on December 17, 1987, 379 days after receiving the submission on December 3, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3700.

Submission Details

510(k) Number K864712 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1986
Decision Date December 17, 1987
Days to Decision 379 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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