Cleared Traditional

K894065 - OPUS MODEL 4001
(FDA 510(k) Clearance)

K894065 · Ela Medical, Inc. · Cardiovascular

Sep 1989

Decision

110d

Days

Class 3

Risk

K894065 is an FDA 510(k) clearance for the OPUS MODEL 4001, 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 26, 1989, 110 days after receiving the submission on June 8, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number	K894065 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 1989
Decision Date	September 26, 1989
Days to Decision	110 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—