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FDA 510(k)

INTEL HEALTH GUIDE

K-Number: K103276 · 2011-02-08

ApplicantIntel Corporation Digital Health Group
Decision Date2011-02-08
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTEL HEALTH GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Intel Corporation Digital Health Group. It received FDA 510(k) clearance on 2011-02-08 under 510(k) number K103276. 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 INTEL HEALTH GUIDE?

INTEL HEALTH GUIDE is a medical device that received FDA 510(k) clearance on 2011-02-08. The listed applicant is Intel Corporation Digital Health Group. The 510(k) number is K103276.

When did INTEL HEALTH GUIDE receive FDA 510(k) clearance?

INTEL HEALTH GUIDE received FDA 510(k) clearance on 2011-02-08, under 510(k) number K103276.

Who is the listed applicant for INTEL HEALTH GUIDE?

The FDA 510(k) record lists Intel Corporation Digital Health Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTEL HEALTH GUIDE?

The FDA product code for INTEL HEALTH GUIDE 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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