Cleared Traditional

UNILITH 3 MODELS 7580/7583/7680/7683

K883037 · Ela Medical, Inc. · Cardiovascular
Jan 1989
Decision
190d
Days
Class 3
Risk

About This 510(k) Submission

K883037 is an FDA 510(k) clearance for the UNILITH 3 MODELS 7580/7583/7680/7683, 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 January 25, 1989, 190 days after receiving the submission on July 19, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K883037 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1988
Decision Date January 25, 1989
Days to Decision 190 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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