Cleared Traditional

K831216 - COMMAND ULTRA II
(FDA 510(k) Clearance)

K831216 · Cardiac Pacemakers, Inc. · Cardiovascular

Jul 1983

Decision

89d

Days

Class 3

Risk

K831216 is an FDA 510(k) clearance for the COMMAND ULTRA II, 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 July 12, 1983, 89 days after receiving the submission on April 14, 1983. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number	K831216 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 1983
Decision Date	July 12, 1983
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—