Cleared Traditional

ULTRA SOFTWARE MODULE: MODEL 2016

K863046 · Cardiac Pacemakers, Inc. · Cardiovascular
Dec 1986
Decision
115d
Days
Class 3
Risk

About This 510(k) Submission

K863046 is an FDA 510(k) clearance for the ULTRA SOFTWARE MODULE: MODEL 2016, a Programmer, Pacemaker (Class III — Premarket Approval, product code KRG), submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 5, 1986, 115 days after receiving the submission on August 12, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3700.

Submission Details

510(k) Number K863046 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1986
Decision Date December 05, 1986
Days to Decision 115 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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