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FDA 510(k)

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System

K-Number: K234134 · 2024-09-24

ApplicantResmed Pty Ltd (Registration Number: 3004604967)
Decision Date2024-09-24
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System is a medical device manufactured by Resmed Pty Ltd (Registration Number: 3004604967). It received FDA 510(k) clearance on 2024-09-24 under approval number K234134. 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 AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System?

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System is a medical device that received FDA 510(k) clearance on 2024-09-24. It is manufactured by Resmed Pty Ltd (Registration Number: 3004604967). The 510(k) number is K234134.

When was AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System approved by the FDA?

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System received FDA 510(k) clearance on 2024-09-24, under approval number K234134.

What company makes AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System?

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System is manufactured by Resmed Pty Ltd (Registration Number: 3004604967).

What is the FDA product code for AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System?

The FDA product code for AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System is BZD.

Related Clinical Trials

NCT05255744 Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol TERMINATED

Other Devices by Resmed Pty Ltd (Registration Number: 3004604967)

K230476Oran Park Mask K223747Whitsundays Mask 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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