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510(k) Data Aggregation
K Number
K962312Device Name
KEY CHAIN EMERGENCY AIRWAYManufacturer
Date Cleared
1997-06-17
(365 days)
Product Code
Regulation Number
868.5090Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
FFRENCH POCKET EMERGENCY AIRWAY, INC.
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.
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