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FDA 510(k)

AirPhysio Positive Expiratory Pressure (PEP) Device

K-Number: K203209 · 2021-01-15

ApplicantAirphysio Pty, Ltd.
Decision Date2021-01-15
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AirPhysio Positive Expiratory Pressure (PEP) Device is the device name listed in this FDA 510(k) record. The listed applicant is Airphysio Pty, Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K203209. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirPhysio Positive Expiratory Pressure (PEP) Device?

AirPhysio Positive Expiratory Pressure (PEP) Device is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Airphysio Pty, Ltd.. The 510(k) number is K203209.

When did AirPhysio Positive Expiratory Pressure (PEP) Device receive FDA 510(k) clearance?

AirPhysio Positive Expiratory Pressure (PEP) Device received FDA 510(k) clearance on 2021-01-15, under 510(k) number K203209.

Who is the listed applicant for AirPhysio Positive Expiratory Pressure (PEP) Device?

The FDA 510(k) record lists Airphysio Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirPhysio Positive Expiratory Pressure (PEP) Device?

The FDA product code for AirPhysio Positive Expiratory Pressure (PEP) Device is BYI.

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.

NCT05938738PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of ActionRECRUITINGNCT07404826PEP Buddy in Pulmonary RehabilitationRECRUITING

Related Devices (Code: BYI)

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.

K252849AffloVest® Mobile Airway Clearance TherapyTactile MedicalK250860BreatheBand® (Model 1000)Exemplar Medical, LLCK242063LibAirty Airway Clearance SystemSynchrony Medical , Ltd.K240959Respiratory Muscle TrainerChongqing Moffy Innovation Technology Co., Ltd.K233441The Vest APX System (PVAPX1)Baxter Healthcare CorportationK222496Electromed SmartVest Airway Clearance SystemElectromed, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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