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K Number
K962492
Device Name
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
Manufacturer
NIDEK MEDICAL PRODUCTS, INC.
Date Cleared
1997-01-23

(211 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
Device Description
AI/ML Overview

§ 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).