MetaNeb 4 System— 510(k) K151689

Name: FDA 510(k) clearance K151689
Creator: U.S. Food and Drug Administration
Published: 2016-03-17

Substantially Equivalent

Hill-Rom Services Pte, Ltd.

FDA 510(k) clearance K151689 for MetaNeb 4 System, Substantially Equivalent on 2016-03-17. Applicant: Hill-Rom Services Pte, Ltd.. Device class: 2.

Clearance details

Applicant: Hill-Rom Services Pte, Ltd.
Product code: Code NHJ
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2015-06-23
Decision date: 2016-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NHJ

product code NHJ

Death: 7
Total: 7

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.