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K Number
K050309
Device Name
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
Manufacturer
VIASYS MEDSYSTEMS
Date Cleared
2005-03-25

(45 days)

Product Code
CAP
Regulation Number
868.2600
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PULMANEX® Disposable Manometer is designed to provide visual indication of a pediatric/infant/neonate's airway pressure during ventilation. It may be attached to the manometer port on manual ventilation devices such as resuscitation bags or hyperinflation bags.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter for the PULMANEX® Disposable Pressure Manometer. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert ground truth establishment, or AI-related details. The letter confirms substantial equivalence to a predicate device but does not detail the testing or validation studies performed.

Therefore, I cannot provide the requested information based on the input text.

§ 868.2600 Airway pressure monitor.

(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).