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K Number
K962312
Device Name
KEY CHAIN EMERGENCY AIRWAY
Manufacturer
FFRENCH POCKET EMERGENCY AIRWAY, INC.
Date Cleared
1997-06-17

(365 days)

Product Code
BWC
Regulation Number
868.5090
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for emergency airway obstruction in a non-clinical environment. The device is intended to be used for less than 24 hours.

Device Description

Not Found

AI/ML Overview

I am sorry. I cannot provide information about acceptance criteria and study details based on the provided text. The document is a 1997 FDA 510(k) clearance letter for a "ffrench Pocket Emergency Airway" device. It confirms the device's substantial equivalence to a predicate device and its classification.

The letter does not include:

  • A table of acceptance criteria or reported device performance.
  • Details about a specific study, sample sizes, data provenance, expert qualifications, or adjudication methods.
  • Information on MRMC comparative effectiveness studies, standalone performance, or ground truth types and how they were established.

This document is solely an FDA clearance letter, not a clinical study report or a summary of performance data.

§ 868.5090 Emergency airway needle.

(a)
Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.(b)
Classification. Class II (performance standards).