K781568Substantially Equivalent

Pacemaker, Model 251-01

Name: K781568 Pacemaker, Model 251-01
Creator: Intermedics, Inc.
Published: 1978-10-18
License: https://open.fda.gov/license/

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

FDA source

K781568 is the FDA 510(k) clearance record for PACEMAKER, MODEL 251-01, cleared for Intermedics, Inc. on 1978-10-18. FDA records list 211 510(k) clearances for Intermedics, Inc., from 1977-09-12 to 1996-12-16. As of 2026-09-10, FDA records show no recalls naming K781568.

Clearance record

Decision date: 1978-10-18
Received: 1978-09-14 (34 days to decision)
Review panel: Unknown
Applicant: Intermedics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No