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FDA 510(k)

Livocare Surgical Mask

K-Number: K201380 · 2020-10-07

ApplicantAndon Health Co, Ltd.
Decision Date2020-10-07
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Livocare Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2020-10-07 under 510(k) number K201380. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Livocare Surgical Mask?

Livocare Surgical Mask is a medical device that received FDA 510(k) clearance on 2020-10-07. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K201380.

When did Livocare Surgical Mask receive FDA 510(k) clearance?

Livocare Surgical Mask received FDA 510(k) clearance on 2020-10-07, under 510(k) number K201380.

Who is the listed applicant for Livocare Surgical Mask?

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

What is the FDA product code for Livocare Surgical Mask?

The FDA product code for Livocare Surgical Mask is FXX.

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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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