LogoFDA 510(k) Search
K Number
K963755
Device Name
SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
Manufacturer
SPIRACLE TECHNOLOGY
Date Cleared
1997-04-08

(202 days)

Product Code
CBP
Regulation Number
868.5870
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5870 Nonrebreathing valve.

(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).