Cleared Traditional

K882391 - OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
(FDA 510(k) Clearance)

K882391 · Ela Medical, Inc. · Cardiovascular

Nov 1988

Decision

157d

Days

Class 3

Risk

K882391 is an FDA 510(k) clearance for the OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024. This device is classified as 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 November 14, 1988, 157 days after receiving the submission on June 10, 1988.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number	K882391 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 1988
Decision Date	November 14, 1988
Days to Decision	157 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—