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FDA 510(k)

AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE

K-Number: K123400 · 2013-05-16

ApplicantTrudell Medical Intl.
Decision Date2013-05-16
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical Intl.. It received FDA 510(k) clearance on 2013-05-16 under 510(k) number K123400. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE?

AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE is a medical device that received FDA 510(k) clearance on 2013-05-16. The listed applicant is Trudell Medical Intl.. The 510(k) number is K123400.

When did AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE receive FDA 510(k) clearance?

AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE received FDA 510(k) clearance on 2013-05-16, under 510(k) number K123400.

Who is the listed applicant for AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE?

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

What is the FDA product code for AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE?

The FDA product code for AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE is BWF.

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Other records listing Trudell Medical Intl. 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.

K131881OMBRA TABLE TOP COMPRESSORK123614SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)K112010AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)K110136RESPICHAMBER VALVED HOLDING CHAMBERK090065AEROCHAMBER MINI VENTILATION CHAMBERK080926AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER

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Related Devices (Code: BWF)

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.

K241152InSeeTidal Medical Technologies, LLCK233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLCK222018Breathe+Peep Medical, LLC Dba Go2 DevicesK220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc.K203378PulsehalerRespinova, Ltd.

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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