WiZARD 310/320 Series CPAP Mask
K-Number: K182394 · 2019-05-17
ApplicantApex Medical Corp.
Decision Date2019-05-17
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
WiZARD 310/320 Series CPAP Mask is a medical device manufactured by Apex Medical Corp.. It received FDA 510(k) clearance on 2019-05-17 under approval number K182394. 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 310/320 Series CPAP Mask?
WiZARD 310/320 Series CPAP Mask is a medical device that received FDA 510(k) clearance on 2019-05-17. It is manufactured by Apex Medical Corp.. The 510(k) number is K182394.
When was WiZARD 310/320 Series CPAP Mask approved by the FDA?
WiZARD 310/320 Series CPAP Mask received FDA 510(k) clearance on 2019-05-17, under approval number K182394.
What company makes WiZARD 310/320 Series CPAP Mask?
WiZARD 310/320 Series CPAP Mask is manufactured by Apex Medical Corp..
What is the FDA product code for WiZARD 310/320 Series CPAP Mask?
The FDA product code for WiZARD 310/320 Series CPAP Mask is BZD.
Other Devices by Apex Medical Corp.
Related Devices (Code: BZD)
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.