Huxley SANSA Home Sleep Apnea Test (1000-00)— 510(k) K240285

Name: FDA 510(k) clearance K240285
Creator: U.S. Food and Drug Administration
Published: 2024-07-15

Substantially Equivalent

Huxley Medical

FDA 510(k) clearance K240285 for Huxley SANSA Home Sleep Apnea Test (1000-00), Substantially Equivalent on 2024-07-15. Applicant: Huxley Medical. Device class: 2.

Clearance details

Applicant: Huxley Medical
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2024-02-01
Decision date: 2024-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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