K854026Substantially Equivalent

Vedlar Ventilator (Modification)

Name: K854026 Vedlar Ventilator (Modification)
Creator: Hamilton Medical, Inc.
Published: 1985-10-23
License: https://open.fda.gov/license/

Hamilton Medical AG, Reno NV / Traditional, Substantially Equivalent

FDA source

K854026 is the FDA 510(k) clearance record for VEDLAR VENTILATOR (MODIFICATION), cleared for Hamilton Medical, Inc. on 1985-10-23. FDA records list 45 510(k) clearances for Hamilton Medical, Inc., from 1985-06-27 to 2021-02-05. As of 2026-09-10, FDA records show no recalls naming K854026.

Clearance record

Decision date: 1985-10-23
Received: 1985-08-26 (58 days to decision)
Review panel: Unknown
Applicant: Hamilton Medical, Inc. P.O. Box 30008, Reno NV
Third party review: No