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FDA 510(k)

WiZARD 510 Nasal Mask

K-Number: K193206 · 2020-10-29

ApplicantApex Medical Corp.
Decision Date2020-10-29
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WiZARD 510 Nasal Mask is a medical device manufactured by Apex Medical Corp.. It received FDA 510(k) clearance on 2020-10-29 under approval number K193206. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WiZARD 510 Nasal Mask?

WiZARD 510 Nasal Mask is a medical device that received FDA 510(k) clearance on 2020-10-29. It is manufactured by Apex Medical Corp.. The 510(k) number is K193206.

When was WiZARD 510 Nasal Mask approved by the FDA?

WiZARD 510 Nasal Mask received FDA 510(k) clearance on 2020-10-29, under approval number K193206.

What company makes WiZARD 510 Nasal Mask?

WiZARD 510 Nasal Mask is manufactured by Apex Medical Corp..

What is the FDA product code for WiZARD 510 Nasal Mask?

The FDA product code for WiZARD 510 Nasal Mask is BZD.

Other Devices by Apex Medical Corp.

K182394WiZARD 310/320 Series CPAP Mask K213577VenAir, Sequential Compression System

Related Devices (Code: BZD)

K160836Menai SystemResmed, Ltd. K161978AirFit N20Resmed, Ltd. K160127iCodeConnect3B Medical, Inc. K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. K153387Luna CPAP and Auto CPAP System3B Medical, 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.

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