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FDA 510(k)

AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER

K-Number: K080926 · 2008-08-12

ApplicantTrudell Medical Intl.
Decision Date2008-08-12
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER 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 2008-08-12 under 510(k) number K080926. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER?

AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER is a medical device that received FDA 510(k) clearance on 2008-08-12. The listed applicant is Trudell Medical Intl.. The 510(k) number is K080926.

When did AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER receive FDA 510(k) clearance?

AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER received FDA 510(k) clearance on 2008-08-12, under 510(k) number K080926.

Who is the listed applicant for AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER?

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 AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER?

The FDA product code for AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER is CAF.

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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 COMPRESSORK123400AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICEK123614SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)K112010AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)K110136RESPICHAMBER VALVED HOLDING CHAMBERK090065AEROCHAMBER MINI VENTILATION CHAMBER

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Related Devices (Code: CAF)

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.

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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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