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K Number
K070120
Device Name
AUTOVENT MODEL 4000
Manufacturer
ALLIED HEALTHCARE PRODUCTS, INC.
Date Cleared
2007-05-03

(111 days)

Product Code
BTL
Regulation Number
868.5925
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Autovent 4000 is a powered emergency transport ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway.

Device Description

Autovent 4000

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for a device called "Autovent 4000." It primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and regulatory compliance.

Unfortunately, the document does not contain information about acceptance criteria, detailed study designs, sample sizes for test or training sets, expert qualifications, or ground truth establishment. The letter is a regulatory approval document, not a scientific study report.

Therefore, I cannot extract the requested information from the provided text.

§ 868.5925 Powered emergency ventilator.

(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).