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FDA 510(k)

VIGNET TELEHEALTH MANAGER

K-Number: K113446 · 2012-07-16

ApplicantVignet, Inc.
Decision Date2012-07-16
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIGNET TELEHEALTH MANAGER is the device name listed in this FDA 510(k) record. The listed applicant is Vignet, Inc.. It received FDA 510(k) clearance on 2012-07-16 under 510(k) number K113446. 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 VIGNET TELEHEALTH MANAGER?

VIGNET TELEHEALTH MANAGER is a medical device that received FDA 510(k) clearance on 2012-07-16. The listed applicant is Vignet, Inc.. The 510(k) number is K113446.

When did VIGNET TELEHEALTH MANAGER receive FDA 510(k) clearance?

VIGNET TELEHEALTH MANAGER received FDA 510(k) clearance on 2012-07-16, under 510(k) number K113446.

Who is the listed applicant for VIGNET TELEHEALTH MANAGER?

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

What is the FDA product code for VIGNET TELEHEALTH MANAGER?

The FDA product code for VIGNET TELEHEALTH MANAGER 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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