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Apex Medical Wizard Series Cpap Mask

by Apex Medical Corp.

510(k) K103174

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

The APEX MEDICAL WIZARD SERIES CPAP MASK is a revolutionary, substantially equivalent device that provides precise ventilation control for patients with sleep apnea. By leveraging advanced technology and user-friendly design, this mask offers unparalleled comfort and effectiveness, making it an ideal solution for individuals seeking to improve their sleep quality.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103174 Date6 May 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BZD
Device Class
Class II
Regulation
21 CFR Part 868.5905
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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