Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OptiPillows EPAP Mask

K-Number: K181219 · 2018-08-03

ApplicantCpapnea Medical Supply
Decision Date2018-08-03
Product CodeLWF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OptiPillows EPAP Mask is a medical device manufactured by Cpapnea Medical Supply. It received FDA 510(k) clearance on 2018-08-03 under approval number K181219. The device is classified under product code LWF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiPillows EPAP Mask?

OptiPillows EPAP Mask is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by Cpapnea Medical Supply. The 510(k) number is K181219.

When was OptiPillows EPAP Mask approved by the FDA?

OptiPillows EPAP Mask received FDA 510(k) clearance on 2018-08-03, under approval number K181219.

What company makes OptiPillows EPAP Mask?

OptiPillows EPAP Mask is manufactured by Cpapnea Medical Supply.

What is the FDA product code for OptiPillows EPAP Mask?

The FDA product code for OptiPillows EPAP Mask is LWF.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑