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)

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask

K-Number: K233555 · 2024-07-31

ApplicantPhilips Respironics
Decision Date2024-07-31
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Philips Respironics. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K233555. 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 AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask?

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Philips Respironics. The 510(k) number is K233555.

When did AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask receive FDA 510(k) clearance?

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask received FDA 510(k) clearance on 2024-07-31, under 510(k) number K233555.

Who is the listed applicant for AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask?

The FDA 510(k) record lists Philips Respironics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask?

The FDA product code for AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask is BZD.

Related Clinical Trials

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.

NCT03554863High Flow Oxygen in Patients Undergoing Surgery Under General AnesthesiaCOMPLETEDNCT07019701Gas Composition in the Hypopharynx During High-flow or Standard Oxygen Therapy Through Face Mask in Healthy VolunteersCOMPLETEDNCT07432607High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window SurgeryRECRUITINGNCT07558265WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency DepartmentNOT_YET_RECRUITINGNCT07718295HFNO Versus Face Mask for Cerebral Oxygenation During Procedural SedationRECRUITINGNCT07723430Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence InductionNOT_YET_RECRUITING

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.

↑