K811401Substantially Equivalent

Command P5(unipolar Pulse Generator)

Name: K811401 Command P5(unipolar Pulse Generator)
Creator: Cardiac Pacemakers, Inc.
Published: 1981-07-27
License: https://open.fda.gov/license/

Cardiac Pacemakers, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K811401 is the FDA 510(k) clearance record for COMMAND P5(UNIPOLAR PULSE GENERATOR), cleared for Cardiac Pacemakers, Inc. on 1981-07-27. FDA records list 76 510(k) clearances for Cardiac Pacemakers, Inc., from 1977-01-12 to 2010-03-05. As of 2026-09-10, FDA records show no recalls naming K811401.

Clearance record

Decision date: 1981-07-27
Received: 1981-05-19 (69 days to decision)
Review panel: Unknown
Applicant: Cardiac Pacemakers, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No