Cleared Traditional

Huxley SANSA Home Sleep Apnea Test (1000-00)

K240285 · Huxley Medical · Anesthesiology

Jul 2024

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K240285 is an FDA 510(k) clearance for the Huxley SANSA Home Sleep Apnea Test (1000-00), a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Huxley Medical (Atlanta, US). The FDA issued a Cleared decision on July 15, 2024, 165 days after receiving the submission on February 1, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number	K240285 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2024
Decision Date	July 15, 2024
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF