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K Number
K990098
Device Name
VENTLAB VERIFY II
Manufacturer
VENTLAB CORP.
Date Cleared
1999-02-11

(30 days)

Product Code
BTR
Regulation Number
868.5730
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Ventlab Verify II is designed to assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation and does not eliminate clinical judgment.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request regarding acceptance criteria and study details for the Ventlab Verify II device. The document is an FDA 510(k) clearance letter, confirming the device's substantial equivalence to a predicate device, but it does not include performance data, study design, sample sizes, or ground truth establishment.

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).