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FDA 510(k)

OPTUM TELEHEALTH APPLICATION

K-Number: K130971 · 2013-10-23

ApplicantOptumhealth Care Solutions, Inc.
Decision Date2013-10-23
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPTUM TELEHEALTH APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Optumhealth Care Solutions, Inc.. It received FDA 510(k) clearance on 2013-10-23 under 510(k) number K130971. 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 OPTUM TELEHEALTH APPLICATION?

OPTUM TELEHEALTH APPLICATION is a medical device that received FDA 510(k) clearance on 2013-10-23. The listed applicant is Optumhealth Care Solutions, Inc.. The 510(k) number is K130971.

When did OPTUM TELEHEALTH APPLICATION receive FDA 510(k) clearance?

OPTUM TELEHEALTH APPLICATION received FDA 510(k) clearance on 2013-10-23, under 510(k) number K130971.

Who is the listed applicant for OPTUM TELEHEALTH APPLICATION?

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

What is the FDA product code for OPTUM TELEHEALTH APPLICATION?

The FDA product code for OPTUM TELEHEALTH APPLICATION 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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