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FDA 510(k)

DURA NEB(TM) 2000 PORTABLE COMPRESSOR

K-Number: K863339 · 1986-10-07

ApplicantThera Tec, Inc.
Decision Date1986-10-07
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DURA NEB(TM) 2000 PORTABLE COMPRESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Thera Tec, Inc.. It received FDA 510(k) clearance on 1986-10-07 under 510(k) number K863339. 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 DURA NEB(TM) 2000 PORTABLE COMPRESSOR?

DURA NEB(TM) 2000 PORTABLE COMPRESSOR is a medical device that received FDA 510(k) clearance on 1986-10-07. The listed applicant is Thera Tec, Inc.. The 510(k) number is K863339.

When did DURA NEB(TM) 2000 PORTABLE COMPRESSOR receive FDA 510(k) clearance?

DURA NEB(TM) 2000 PORTABLE COMPRESSOR received FDA 510(k) clearance on 1986-10-07, under 510(k) number K863339.

Who is the listed applicant for DURA NEB(TM) 2000 PORTABLE COMPRESSOR?

The FDA 510(k) record lists Thera Tec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURA NEB(TM) 2000 PORTABLE COMPRESSOR?

The FDA product code for DURA NEB(TM) 2000 PORTABLE COMPRESSOR is BTI.

Related Clinical Trials

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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.

K131881OMBRA TABLE TOP COMPRESSORTrudell Medical Intl.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.

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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