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K Number
K952267
Device Name
CRITERION, CRITERION I.V., MODIFIED
Manufacturer
NOVA-VENTRX
Date Cleared
1997-12-02

(932 days)

Product Code
BZE
Regulation Number
868.5270
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

HYDRO-HEAT® Condensate Control System

AI/ML Overview

I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) clearance for a device called the "HYDRO-HEAT® Condensate Control System." It discusses regulatory classifications, general controls, and compliance.

However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other details you've requested about device performance and validation.

Therefore, I cannot fulfill your request for this specific device based on the provided text.

§ 868.5270 Breathing system heater.

(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).