Cleared Traditional

CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066

K882427 · Ela Medical, Inc. · Cardiovascular
Sep 1988
Decision
102d
Days
Class 3
Risk

About This 510(k) Submission

K882427 is an FDA 510(k) clearance for the CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066, a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY), submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on September 23, 1988, 102 days after receiving the submission on June 13, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K882427 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 1988
Decision Date September 23, 1988
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DXY — Implantable Pacemaker Pulse-generator
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3610

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