K854036Substantially Equivalent

Manual Ventilation Accessory

Name: K854036 Manual Ventilation Accessory
Creator: Siemens Elema AB
Published: 1985-10-23
License: https://open.fda.gov/license/

Siemens Elema AB, Schaumburg IL / Traditional, Substantially Equivalent

FDA source

K854036 is the FDA 510(k) clearance record for MANUAL VENTILATION ACCESSORY, cleared for Siemens Elema AB on 1985-10-23. FDA records list 63 510(k) clearances for Siemens Elema AB, from 1978-09-14 to 2003-09-05. As of 2026-09-10, FDA records show no recalls naming K854036.

Clearance record

Decision date: 1985-10-23
Received: 1985-08-27 (57 days to decision)
Review panel: Unknown
Applicant: Siemens Elema AB 2360 N. Palmer Dr., Schaumburg IL
Third party review: No