OptiPillows EPAP Mask— 510(k) K181219

Substantially Equivalent

Cpapnea Medical Supply

FDA 510(k) clearance K181219 for OptiPillows EPAP Mask, Substantially Equivalent on 2018-08-03. Applicant: Cpapnea Medical Supply. Device class: 1.

Clearance details

Applicant: Cpapnea Medical Supply
Product code: Code LWF
Device class: Class 1
Regulation: 21 CFR 874.3900
Advisory panel: Ear, Nose, Throat
Date received: 2018-05-07
Decision date: 2018-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.