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FDA 510(k)

Thermoplastic Masks

K-Number: K192102 · 2019-09-25

ApplicantAktina Medical Corporation
Decision Date2019-09-25
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Thermoplastic Masks is the device name listed in this FDA 510(k) record. The listed applicant is Aktina Medical Corporation. It received FDA 510(k) clearance on 2019-09-25 under 510(k) number K192102. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thermoplastic Masks?

Thermoplastic Masks is a medical device that received FDA 510(k) clearance on 2019-09-25. The listed applicant is Aktina Medical Corporation. The 510(k) number is K192102.

When did Thermoplastic Masks receive FDA 510(k) clearance?

Thermoplastic Masks received FDA 510(k) clearance on 2019-09-25, under 510(k) number K192102.

Who is the listed applicant for Thermoplastic Masks?

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

What is the FDA product code for Thermoplastic Masks?

The FDA product code for Thermoplastic Masks is IYE.

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Related Devices (Code: IYE)

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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.

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