Monarch Airway Clearance System— 510(k) K163378

Substantially Equivalent

Hill-Rom Services Pte, Ltd.

FDA 510(k) clearance K163378 for Monarch Airway Clearance System, Substantially Equivalent on 2017-03-17. Applicant: Hill-Rom Services Pte, Ltd..

Clearance details

Applicant: Hill-Rom Services Pte, Ltd.
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 2016-12-01
Decision date: 2017-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.