Oran Park Mask
K-Number: K230476 · 2023-10-19
Decision Date2023-10-19
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Oran Park Mask is a medical device manufactured by Resmed Pty Ltd (Registration Number: 3004604967). It received FDA 510(k) clearance on 2023-10-19 under approval number K230476. 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 Oran Park Mask?
Oran Park Mask is a medical device that received FDA 510(k) clearance on 2023-10-19. It is manufactured by Resmed Pty Ltd (Registration Number: 3004604967). The 510(k) number is K230476.
When was Oran Park Mask approved by the FDA?
Oran Park Mask received FDA 510(k) clearance on 2023-10-19, under approval number K230476.
What company makes Oran Park Mask?
Oran Park Mask is manufactured by Resmed Pty Ltd (Registration Number: 3004604967).
What is the FDA product code for Oran Park Mask?
The FDA product code for Oran Park Mask is BZD.
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.