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K Number
K973176
Device Name
SEIZURE EMERGENCY EQUIPMENT KIT; SEIZURE KIT
Manufacturer
LOTUS TECHNOLOGIES
Date Cleared
1997-11-21

(88 days)

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

During a seizure emergency, this device is indicated for use by a caretaker to render first aid to a person who is having a seizure.

Device Description

Seizure Emergency Equipment Kit

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Seizure Emergency Equipment Kit." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter is a regulatory approval for marketing the device based on its substantial equivalence to a predicate device already on the market. It confirms that the device can be marketed subject to general controls but does not include details of performance testing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

N/A