Cleared Abbreviated

K080798 - INTEL HEALTH GUIDE

K080798 is an FDA 510(k) clearance for INTEL HEALTH GUIDE, manufactured by Intel Corp.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Abbreviated 510(k) pathway after a 99-day FDA review.

K080798 · Intel Corp. · Cardiovascular device
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Jun 2008
Decision
99d
Days
Class 2
Risk

K080798 is an FDA 510(k) clearance for the INTEL HEALTH GUIDE, MODEL: PHS6000. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Intel Corp. (Folsom, US). The FDA issued a Cleared decision on June 27, 2008 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Intel Corp. devices

FDA 510(k) Submission Details - K080798

510(k) Number K080798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2008
Decision Date June 27, 2008
Days to Decision 99 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Standards-based clearance path.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 75
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