K800603Substantially Equivalent

Implantable Programmable Unipolar Card.

Name: K800603 Implantable Programmable Unipolar Card.
Creator: Telectronics, Inc.
Published: 1980-03-25
License: https://open.fda.gov/license/

Telectronics, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K800603 is the FDA 510(k) clearance record for IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD., cleared for Telectronics, Inc. on 1980-03-25. FDA records list 107 510(k) clearances for Telectronics, Inc., from 1977-09-12 to 1990-03-06. As of 2026-09-10, FDA records show no recalls naming K800603.

Clearance record

Decision date: 1980-03-25
Received: 1980-03-17 (8 days to decision)
Review panel: Unknown
Applicant: Telectronics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No