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FDA 510(k)

TURBO AIR COMPRESSOR 8000

K-Number: K883829 · 1989-03-23

ApplicantNecon Medical, Inc.
Decision Date1989-03-23
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TURBO AIR COMPRESSOR 8000 is the device name listed in this FDA 510(k) record. The listed applicant is Necon Medical, Inc.. It received FDA 510(k) clearance on 1989-03-23 under 510(k) number K883829. 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 TURBO AIR COMPRESSOR 8000?

TURBO AIR COMPRESSOR 8000 is a medical device that received FDA 510(k) clearance on 1989-03-23. The listed applicant is Necon Medical, Inc.. The 510(k) number is K883829.

When did TURBO AIR COMPRESSOR 8000 receive FDA 510(k) clearance?

TURBO AIR COMPRESSOR 8000 received FDA 510(k) clearance on 1989-03-23, under 510(k) number K883829.

Who is the listed applicant for TURBO AIR COMPRESSOR 8000?

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

What is the FDA product code for TURBO AIR COMPRESSOR 8000?

The FDA product code for TURBO AIR COMPRESSOR 8000 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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