Cleared Traditional

COMMAND ULTRA I

K831161 · Cardiac Pacemakers, Inc. · Cardiovascular
Jun 1983
Decision
65d
Days
Class 3
Risk

About This 510(k) Submission

K831161 is an FDA 510(k) clearance for the COMMAND ULTRA I, a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY), submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1983, 65 days after receiving the submission on April 11, 1983. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K831161 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1983
Decision Date June 15, 1983
Days to Decision 65 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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