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FDA 510(k)

OPTI-MIST

K-Number: K820952 · 1982-04-29

ApplicantCorpak Co.
Decision Date1982-04-29
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OPTI-MIST is the device name listed in this FDA 510(k) record. The listed applicant is Corpak Co.. It received FDA 510(k) clearance on 1982-04-29 under 510(k) number K820952. 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 OPTI-MIST?

OPTI-MIST is a medical device that received FDA 510(k) clearance on 1982-04-29. The listed applicant is Corpak Co.. The 510(k) number is K820952.

When did OPTI-MIST receive FDA 510(k) clearance?

OPTI-MIST received FDA 510(k) clearance on 1982-04-29, under 510(k) number K820952.

Who is the listed applicant for OPTI-MIST?

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

What is the FDA product code for OPTI-MIST?

The FDA product code for OPTI-MIST is CAF.

Other records listing Corpak Co. as applicant

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Related Devices (Code: CAF)

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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