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FDA 510(k)

STER-O-MIST 1000 ML

K-Number: K821191 · 1982-05-13

ApplicantInhalation Therapy Equipment, Co.
Decision Date1982-05-13
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STER-O-MIST 1000 ML 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 1982-05-13 under 510(k) number K821191. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STER-O-MIST 1000 ML?

STER-O-MIST 1000 ML is a medical device that received FDA 510(k) clearance on 1982-05-13. The listed applicant is Inhalation Therapy Equipment, Co.. The 510(k) number is K821191.

When did STER-O-MIST 1000 ML receive FDA 510(k) clearance?

STER-O-MIST 1000 ML received FDA 510(k) clearance on 1982-05-13, under 510(k) number K821191.

Who is the listed applicant for STER-O-MIST 1000 ML?

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 STER-O-MIST 1000 ML?

The FDA product code for STER-O-MIST 1000 ML is CAF.

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.

K820128UNI-SETK820227STER-O-DOSE

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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

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