Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AEROSOL ONE

K-Number: K852622 · 1986-04-24

ApplicantAshai Co. , Ltd.
Decision Date1986-04-24
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROSOL ONE 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 1986-04-24 under 510(k) number K852622. 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?

AEROSOL ONE is a medical device that received FDA 510(k) clearance on 1986-04-24. The listed applicant is Ashai Co. , Ltd.. The 510(k) number is K852622.

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

AEROSOL ONE received FDA 510(k) clearance on 1986-04-24, under 510(k) number K852622.

Who is the listed applicant for AEROSOL ONE?

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?

The FDA product code for AEROSOL ONE is BTI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K870428AEROSOL ONE, NEBULIZER PUMPK852620SAFE.N.SUREK852627MAXI-NEBK852624OXY-TWOK852629AERO-MASK TWOK852625OXY-TUBE

View all 12 devices →

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.

↑