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FDA 510(k)

VOCARE MYHEALTH TABLET

K-Number: K111922 · 2011-12-02

ApplicantVocare, Inc.
Decision Date2011-12-02
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VOCARE MYHEALTH TABLET is the device name listed in this FDA 510(k) record. The listed applicant is Vocare, Inc.. It received FDA 510(k) clearance on 2011-12-02 under 510(k) number K111922. 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 VOCARE MYHEALTH TABLET?

VOCARE MYHEALTH TABLET is a medical device that received FDA 510(k) clearance on 2011-12-02. The listed applicant is Vocare, Inc.. The 510(k) number is K111922.

When did VOCARE MYHEALTH TABLET receive FDA 510(k) clearance?

VOCARE MYHEALTH TABLET received FDA 510(k) clearance on 2011-12-02, under 510(k) number K111922.

Who is the listed applicant for VOCARE MYHEALTH TABLET?

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

What is the FDA product code for VOCARE MYHEALTH TABLET?

The FDA product code for VOCARE MYHEALTH TABLET is DRG.

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Other records listing Vocare, Inc. as applicant

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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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