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FDA 510(k)

SCARLET SRF

K-Number: K180872 · 2018-10-11

ApplicantVIOL Co., Ltd.
Decision Date2018-10-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCARLET SRF is a medical device manufactured by VIOL Co., Ltd.. It received FDA 510(k) clearance on 2018-10-11 under approval number K180872. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCARLET SRF?

SCARLET SRF is a medical device that received FDA 510(k) clearance on 2018-10-11. It is manufactured by VIOL Co., Ltd.. The 510(k) number is K180872.

When was SCARLET SRF approved by the FDA?

SCARLET SRF received FDA 510(k) clearance on 2018-10-11, under approval number K180872.

What company makes SCARLET SRF?

SCARLET SRF is manufactured by VIOL Co., Ltd..

What is the FDA product code for SCARLET SRF?

The FDA product code for SCARLET SRF is GEI.

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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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