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510(k) Data Aggregation

K Number

Device Name

XChange Device, XChange System

Manufacturer

Pneuma Therapeutics, Inc.

Date Cleared

2023-01-30

(741 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

Pneuma Therapeutics, Inc.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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