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FDA 510(k)

AIR STAR

K-Number: K920954 · 1992-08-03

ApplicantInfrasonics Corp.
Decision Date1992-08-03
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIR STAR is the device name listed in this FDA 510(k) record. The listed applicant is Infrasonics Corp.. It received FDA 510(k) clearance on 1992-08-03 under 510(k) number K920954. 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 AIR STAR?

AIR STAR is a medical device that received FDA 510(k) clearance on 1992-08-03. The listed applicant is Infrasonics Corp.. The 510(k) number is K920954.

When did AIR STAR receive FDA 510(k) clearance?

AIR STAR received FDA 510(k) clearance on 1992-08-03, under 510(k) number K920954.

Who is the listed applicant for AIR STAR?

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

What is the FDA product code for AIR STAR?

The FDA product code for AIR STAR is BTI.

Other records listing Infrasonics Corp. 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.

K943106ADULT VENTILATORK952878OXY/STAR LOW FLOW BLENDERK934753STAR BREATHING CIRCUITSK922654VENTILATOR ADULT STAR MODIFICATIONK923704INFANT STAR SERIES 500K922477MODEL 105 VENTILATOR, MODIFICATION

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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

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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