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K Number
K002862
Device Name
PRONEB ULTRA MODEL NUMBER 85B0100
Manufacturer
PARI HOLDING CO.
Date Cleared
2001-03-13

(181 days)

Product Code
BTI
Regulation Number
868.6250
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.6250 Portable air compressor.

(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.