FDA 510(k)

UNI-SET

K-Number: K820128 · 1982-03-23

ApplicantInhalation Therapy Equipment, Co.

Decision Date1982-03-23

Product CodeBZO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

UNI-SET is the device name listed in this FDA 510(k) record. The listed applicant is Inhalation Therapy Equipment, Co.. It received FDA 510(k) clearance on 1982-03-23 under 510(k) number K820128. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-SET?

UNI-SET is a medical device that received FDA 510(k) clearance on 1982-03-23. The listed applicant is Inhalation Therapy Equipment, Co.. The 510(k) number is K820128.

When did UNI-SET receive FDA 510(k) clearance?

UNI-SET received FDA 510(k) clearance on 1982-03-23, under 510(k) number K820128.

Who is the listed applicant for UNI-SET?

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

What is the FDA product code for UNI-SET?

The FDA product code for UNI-SET is BZO.

Other records listing Inhalation Therapy Equipment, Co. 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.

K821191STER-O-MIST 1000 ML K820227STER-O-DOSE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.