Cleared Traditional

K842364 - HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
(FDA 510(k) Clearance)

K842364 · Cardiac Pacemakers, Inc. · Cardiovascular

Sep 1984

Decision

98d

Days

Class 3

Risk

K842364 is an FDA 510(k) clearance for the HANDHELD PACEMAKER PROGRAMMER & SOFTWAR, a Programmer, Pacemaker (Class III — Premarket Approval, product code KRG), submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1984, 98 days after receiving the submission on June 18, 1984. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3700.

Submission Details

510(k) Number	K842364 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 1984
Decision Date	September 24, 1984
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—