Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Oran Park Mask

K-Number: K230476 · 2023-10-19

ApplicantResmed Pty Ltd (Registration Number: 3004604967)
Decision Date2023-10-19
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Oran Park Mask is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Pty Ltd (Registration Number: 3004604967). It received FDA 510(k) clearance on 2023-10-19 under 510(k) 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. The listed applicant is Resmed Pty Ltd (Registration Number: 3004604967). The 510(k) number is K230476.

When did Oran Park Mask receive FDA 510(k) clearance?

Oran Park Mask received FDA 510(k) clearance on 2023-10-19, under 510(k) number K230476.

Who is the listed applicant for Oran Park Mask?

The FDA 510(k) record lists Resmed Pty Ltd (Registration Number: 3004604967) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oran Park Mask?

The FDA product code for Oran Park Mask is BZD.

Other records listing Resmed Pty Ltd (Registration Number: 3004604967) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemK223747Whitsundays Mask System

Related Devices (Code: BZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend 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.

↑