NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM— 510(k) K082724

Name: FDA 510(k) clearance K082724
Creator: U.S. Food and Drug Administration
Published: 2008-12-16

Substantially Equivalent

Newport Medical Instruments, Inc.

FDA 510(k) clearance K082724 for NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM, Substantially Equivalent on 2008-12-16. Applicant: Newport Medical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Newport Medical Instruments, Inc.
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2008-09-17
Decision date: 2008-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.