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FDA 510(k)

RESPI-NEB-AEROSOL SYSTEM

K-Number: K830417 · 1983-03-24

ApplicantProfessional Medical Supply, Inc.
Decision Date1983-03-24
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPI-NEB-AEROSOL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Professional Medical Supply, Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830417. 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 RESPI-NEB-AEROSOL SYSTEM?

RESPI-NEB-AEROSOL SYSTEM is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Professional Medical Supply, Inc.. The 510(k) number is K830417.

When did RESPI-NEB-AEROSOL SYSTEM receive FDA 510(k) clearance?

RESPI-NEB-AEROSOL SYSTEM received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830417.

Who is the listed applicant for RESPI-NEB-AEROSOL SYSTEM?

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

What is the FDA product code for RESPI-NEB-AEROSOL SYSTEM?

The FDA product code for RESPI-NEB-AEROSOL SYSTEM is BTI.

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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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