Cleared Special

K101178 - MODIFICATION TO INTEL HEALTH GUIDE PHS6000

K101178 is an FDA 510(k) clearance for MODIFICATION TO INTEL HEALTH GUIDE PHS6000, manufactured by Intel Corp.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Special 510(k) pathway after a 63-day FDA review.

K101178 · Intel Corp. · Cardiovascular device
Download Printable Device Report (PDF)
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Jun 2010
Decision
63d
Days
Class 2
Risk

K101178 is an FDA 510(k) clearance for the MODIFICATION TO INTEL HEALTH GUIDE 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 29, 2010 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Intel Corp. devices

FDA 510(k) Submission Details - K101178

510(k) Number K101178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2010
Decision Date June 29, 2010
Days to Decision 63 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

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 178
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