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FDA 510(k)

AUSTIN INHALATOR

K-Number: K823246 · 1982-12-16

ApplicantEms Industries, Inc.
Decision Date1982-12-16
Product CodeBYX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUSTIN INHALATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ems Industries, Inc.. It received FDA 510(k) clearance on 1982-12-16 under 510(k) number K823246. The device is classified under product code BYX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUSTIN INHALATOR?

AUSTIN INHALATOR is a medical device that received FDA 510(k) clearance on 1982-12-16. The listed applicant is Ems Industries, Inc.. The 510(k) number is K823246.

When did AUSTIN INHALATOR receive FDA 510(k) clearance?

AUSTIN INHALATOR received FDA 510(k) clearance on 1982-12-16, under 510(k) number K823246.

Who is the listed applicant for AUSTIN INHALATOR?

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

What is the FDA product code for AUSTIN INHALATOR?

The FDA product code for AUSTIN INHALATOR is BYX.

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.

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Other records listing Ems Industries, 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.

K823247U-WAY QUICKOLLAR

Related Devices (Code: BYX)

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.

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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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