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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 the device name listed in this FDA 510(k) record. The listed applicant is VIOL Co., Ltd.. It received FDA 510(k) clearance on 2018-10-11 under 510(k) 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. The listed applicant is VIOL Co., Ltd.. The 510(k) number is K180872.

When did SCARLET SRF receive FDA 510(k) clearance?

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

Who is the listed applicant for SCARLET SRF?

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

What is the FDA product code for SCARLET SRF?

The FDA product code for SCARLET SRF is GEI.

Other records listing VIOL Co., Ltd. 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.

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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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