Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Cpapnea Medical Supply. It received FDA 510(k) clearance on 2018-08-03 under 510(k) 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. The listed applicant is Cpapnea Medical Supply. The 510(k) number is K181219.

When did OptiPillows EPAP Mask receive FDA 510(k) clearance?

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

Who is the listed applicant for OptiPillows EPAP Mask?

The FDA 510(k) record lists Cpapnea Medical Supply as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptiPillows EPAP Mask?

The FDA product code for OptiPillows EPAP Mask is LWF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related Devices (Code: LWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120665INVENT SNORING DEVICEVentus Medical, Inc.K040491CHIN-UP STRIPDale Miller, Inc. - the Chin-Up CompanyK982929MAXAIR NASAL DILATOR SYSTEMHnl TechnologiesK963326BREATHE FITCambridge Assoc.K962400AIR MAX EXTERNAL NASAL DILATOR STRIPAmerican White Cross, Inc.K962698ACUTEK'S CLEARPASAGEAcutek Adhesive Specialties, Inc.

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.

↑