NEOPIP PATIENT CIRCUIT WITH PEEP— 510(k) K103833

Name: FDA 510(k) clearance K103833
Creator: U.S. Food and Drug Administration
Published: 2011-04-20

Substantially Equivalent

Neoforce Group, Inc.

FDA 510(k) clearance K103833 for NEOPIP PATIENT CIRCUIT WITH PEEP, Substantially Equivalent on 2011-04-20. Applicant: Neoforce Group, Inc.. Device class: 2.

Clearance details

Applicant: Neoforce Group, Inc.
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 2010-12-30
Decision date: 2011-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ivyland, PA, US

Download summary PDF View on FDA.gov ↗

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K110119 — PRESSURE MANOMETER2011-06-10
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K092085 — ISPIRA RESUSCITATION UNIT2009-10-07
K072021 — NEOPIP INFANT RESUSCITATOR2007-09-12
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Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.