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FDA 510(k)

AEROSOL ONE, NEBULIZER PUMP

K-Number: K870428 · 1987-05-15

ApplicantAshai Co. , Ltd.
Decision Date1987-05-15
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROSOL ONE, NEBULIZER PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Ashai Co. , Ltd.. It received FDA 510(k) clearance on 1987-05-15 under 510(k) number K870428. 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 AEROSOL ONE, NEBULIZER PUMP?

AEROSOL ONE, NEBULIZER PUMP is a medical device that received FDA 510(k) clearance on 1987-05-15. The listed applicant is Ashai Co. , Ltd.. The 510(k) number is K870428.

When did AEROSOL ONE, NEBULIZER PUMP receive FDA 510(k) clearance?

AEROSOL ONE, NEBULIZER PUMP received FDA 510(k) clearance on 1987-05-15, under 510(k) number K870428.

Who is the listed applicant for AEROSOL ONE, NEBULIZER PUMP?

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

What is the FDA product code for AEROSOL ONE, NEBULIZER PUMP?

The FDA product code for AEROSOL ONE, NEBULIZER PUMP is BTI.

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Other records listing Ashai Co. , Ltd. 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.

K852622AEROSOL ONEK852620SAFE.N.SUREK852627MAXI-NEBK852624OXY-TWOK852629AERO-MASK TWOK852625OXY-TUBE

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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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