Cleared Traditional

K894267 - OPUS MODELS 4033 AND 4034
(FDA 510(k) Clearance)

K894267 · Ela Medical, Inc. · Cardiovascular

Sep 1989

Decision

90d

Days

Class 3

Risk

K894267 is an FDA 510(k) clearance for the OPUS MODELS 4033 AND 4034, 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 20, 1989, 90 days after receiving the submission on June 22, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number	K894267 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 1989
Decision Date	September 20, 1989
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—