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510(k) Data Aggregation

K Number

Device Name

AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask

Manufacturer

Vyaire Medical, Inc.

Date Cleared

2024-11-12

(592 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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