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FDA 510(k)

OMBRA TABLE TOP COMPRESSOR

K-Number: K131881 · 2013-10-24

ApplicantTrudell Medical Intl.
Decision Date2013-10-24
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OMBRA TABLE TOP COMPRESSOR 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 2013-10-24 under 510(k) number K131881. The device is classified under product code BTI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMBRA TABLE TOP COMPRESSOR?

OMBRA TABLE TOP COMPRESSOR is a medical device that received FDA 510(k) clearance on 2013-10-24. The listed applicant is Trudell Medical Intl.. The 510(k) number is K131881.

When did OMBRA TABLE TOP COMPRESSOR receive FDA 510(k) clearance?

OMBRA TABLE TOP COMPRESSOR received FDA 510(k) clearance on 2013-10-24, under 510(k) number K131881.

Who is the listed applicant for OMBRA TABLE TOP COMPRESSOR?

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 OMBRA TABLE TOP COMPRESSOR?

The FDA product code for OMBRA TABLE TOP COMPRESSOR is BTI.

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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.

K123400AEROBIKA 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 CHAMBERK080926AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER

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Related Devices (Code: BTI)

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.

K113338MEDICAL AIR COMPRESSOROricare, Inc.K091871DK50 DSEkom S.R.O.K072634EMG TRITON -COMP,MODEL NCA01-XXX SERIESEmg Technology Co., Ltd.K060781MEDICAL COMPRESSOR, MODELS DK50 D AND DMEkom S.R.O.K051691MINIMATE COMPRESSORPrecision Medical, Inc.K041781VENTILAIR II MEDICAL AIR COMPRESSORHamilton Medical AG

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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