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Found 2 results

510(k) Data Aggregation

K Number

Device Name

FreeStyle Comfort (AS200 / FreeStyle Comfort)

Manufacturer

CAIRE Inc.

Date Cleared

2025-07-11

(128 days)

Product Code

CAW

Regulation Number

868.5440

Why did this record match?

Applicant Name (Manufacturer) :

CAIRE Inc.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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K Number

Device Name

CAIRE COMPANION 5 OXYGEN CONCENTRATOR

Manufacturer

CAIRE INC.

Date Cleared

2012-05-02

(15 days)

Product Code

CAW

Regulation Number

868.5440

Why did this record match?

Applicant Name (Manufacturer) :

CAIRE INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The CAIRE Companion 5, Oxygen Concentrator, is Intended for the administration of supplemental oxygen up to 5 liters/minute. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Device Description

Not Found

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