Whitsundays Mask System
K-Number: K223747 · 2023-07-06
Decision Date2023-07-06
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Whitsundays Mask System is a medical device manufactured by Resmed Pty Ltd (Registration Number: 3004604967). It received FDA 510(k) clearance on 2023-07-06 under approval number K223747. 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 Whitsundays Mask System?
Whitsundays Mask System is a medical device that received FDA 510(k) clearance on 2023-07-06. It is manufactured by Resmed Pty Ltd (Registration Number: 3004604967). The 510(k) number is K223747.
When was Whitsundays Mask System approved by the FDA?
Whitsundays Mask System received FDA 510(k) clearance on 2023-07-06, under approval number K223747.
What company makes Whitsundays Mask System?
Whitsundays Mask System is manufactured by Resmed Pty Ltd (Registration Number: 3004604967).
What is the FDA product code for Whitsundays Mask System?
The FDA product code for Whitsundays Mask System is BZD.
Related Clinical Trials
Other Devices by Resmed Pty Ltd (Registration Number: 3004604967)
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.