K843001Unknown

Cook Pacemaker Corp. 116 Biopolar Cardi

Name: K843001 Cook Pacemaker Corp. 116 Biopolar Cardi
Creator: Cook Pacemaker Corp.
Published: 1984-07-30
License: https://open.fda.gov/license/

Cook Pacemaker Corp., Walker MI / Traditional, Unknown

FDA source

K843001 is the FDA 510(k) clearance record for COOK PACEMAKER CORP. 116 BIOPOLAR CARDI, cleared for Cook Pacemaker Corp. on 1984-07-30. FDA records list 34 510(k) clearances for Cook Pacemaker Corp., from 1981-06-16 to 1997-05-20. As of 2026-09-10, FDA records show no recalls naming K843001.

Clearance record

Decision date: 1984-07-30
Received: 1984-07-30 (0 days to decision)
Review panel: Unknown
Applicant: Cook Pacemaker Corp. 4221 Richmond Rd., NW, Walker MI
Third party review: No