Search Results
Found 1 results
510(k) Data Aggregation
K Number
K963591Device Name
SNORING CONTROL DEVICEManufacturer
Date Cleared
1998-01-09
(487 days)
Product Code
Regulation Number
872.5570Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SNORING CONTROL DEVICE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Anti-Snoring Device is intended to alleviate or correct snoring.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text is a 510(k) clearance letter for a "Snoring Control Device" and an "Indications For Use" statement. This document does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications as requested. Therefore, I cannot generate the specific information you are looking for.
Ask a Question
Ask a specific question about this device
Page 1 of 1