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K Number
K982016
Device Name
PIPER IPPB MODEL 2055
Manufacturer
VORTRAN MEDICAL TECHNOLOGY 1, INC.
Date Cleared
1998-11-03

(148 days)

Product Code
NHJ
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use in delivering intermittent positive pressure aerosol treatment on patients with a body weight greater than 30 kg (adults).

Device Description

Piper IPPB™ Model 2055

AI/ML Overview

I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an "Indication for Use" statement for the Piper IPPB™ Model 2055. It does not include any information about acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailing performance studies and their acceptance criteria.

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).