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K Number
K081266
Device Name
MERCURY MEDICAL PEEP VALVE
Manufacturer
MERCURY ENTERPRIZES DBA MERCURY MEDICAL
Date Cleared
2009-03-05

(304 days)

Product Code
BYE
Regulation Number
868.5965
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Mercury Medical PEEP Valve is a single patient use device that is attached to manual resuscitators and portable ventilators and is used to provide positiveend expiratory pressure. The device is adjustable from 0-20 cm H2O pressure.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested about acceptance criteria and a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a PEEP Valve, indicating that the device has been found substantially equivalent to a predicate device. It defines the device's indications for use but does not detail specific acceptance criteria, study methodologies, or performance results.

§ 868.5965 Positive end expiratory pressure breathing attachment.

(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).