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510(k) Data Aggregation

K Number

Device Name

Aerogen Pro-X1 Controller System

Manufacturer

Date Cleared

2025-09-02

(98 days)

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Type

Panel

Anesthesiology (AN)

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N/A

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Device Name :

Aerogen Pro-X1 Controller System

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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AI/ML Overview

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