Cleared Traditional

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)

K952364 · Ela Medical, Inc. · Cardiovascular
Sep 1995
Decision
123d
Days
Class 3
Risk

About This 510(k) Submission

K952364 is an FDA 510(k) clearance for the OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024), 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 1, 1995, 123 days after receiving the submission on May 1, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K952364 FDA.gov
FDA Decision Cleared ST
Date Received May 01, 1995
Decision Date September 01, 1995
Days to Decision 123 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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