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FDA 510(k)

NEBULIZER SYSTEM

K-Number: K922623 · 1992-12-01

ApplicantHealthdyne, Inc.
Decision Date1992-12-01
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEBULIZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1992-12-01 under 510(k) number K922623. 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 NEBULIZER SYSTEM?

NEBULIZER SYSTEM is a medical device that received FDA 510(k) clearance on 1992-12-01. The listed applicant is Healthdyne, Inc.. The 510(k) number is K922623.

When did NEBULIZER SYSTEM receive FDA 510(k) clearance?

NEBULIZER SYSTEM received FDA 510(k) clearance on 1992-12-01, under 510(k) number K922623.

Who is the listed applicant for NEBULIZER SYSTEM?

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

What is the FDA product code for NEBULIZER SYSTEM?

The FDA product code for NEBULIZER SYSTEM is BTI.

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Other records listing Healthdyne, Inc. 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.

K950331PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)K922106ALICEK942357H-500 ALLIANCE OXYGEN CONCENTRATORK934502FLOW SPIROMETERK924146OH-500 OXYGEN CONCENTRATORK910118DATA RECORDER

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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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