Devices · Huxley Medical

Huxley SANSA Home Sleep Apnea Test (1000-00)

Huxley Medical is listed for Huxley SANSA Home Sleep Apnea Test (1000-00) (K240285). The FDA list gives July 15, 2024 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MNR. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240285

Official FDA database record

Date of final decision

July 15, 2024

Company on the FDA list

Huxley Medical

Lead panel

Anesthesiology

Primary product code

MNR

openFDA device name for the code

Ventilatory Effort Recorder

Device class

2

Regulation number

868.2375

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary