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FDA 510(k)

Vitls Platform

K-Number: K191620 · 2020-06-01

ApplicantVitls, Inc.
Decision Date2020-06-01
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vitls Platform is the device name listed in this FDA 510(k) record. The listed applicant is Vitls, Inc.. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K191620. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vitls Platform?

Vitls Platform is a medical device that received FDA 510(k) clearance on 2020-06-01. The listed applicant is Vitls, Inc.. The 510(k) number is K191620.

When did Vitls Platform receive FDA 510(k) clearance?

Vitls Platform received FDA 510(k) clearance on 2020-06-01, under 510(k) number K191620.

Who is the listed applicant for Vitls Platform?

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

What is the FDA product code for Vitls Platform?

The FDA product code for Vitls Platform is DRG.

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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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