Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INTEL HEALTH GUIDE, MODEL: PHS6000

K-Number: K080798 · 2008-06-27

ApplicantIntel Corp.
Decision Date2008-06-27
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTEL HEALTH GUIDE, MODEL: PHS6000 is the device name listed in this FDA 510(k) record. The listed applicant is Intel Corp.. It received FDA 510(k) clearance on 2008-06-27 under 510(k) number K080798. 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, MODEL: PHS6000?

INTEL HEALTH GUIDE, MODEL: PHS6000 is a medical device that received FDA 510(k) clearance on 2008-06-27. The listed applicant is Intel Corp.. The 510(k) number is K080798.

When did INTEL HEALTH GUIDE, MODEL: PHS6000 receive FDA 510(k) clearance?

INTEL HEALTH GUIDE, MODEL: PHS6000 received FDA 510(k) clearance on 2008-06-27, under 510(k) number K080798.

Who is the listed applicant for INTEL HEALTH GUIDE, MODEL: PHS6000?

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

What is the FDA product code for INTEL HEALTH GUIDE, MODEL: PHS6000?

The FDA product code for INTEL HEALTH GUIDE, MODEL: PHS6000 is DRG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Intel Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K101178MODIFICATION TO INTEL HEALTH GUIDE PHS6000K083115MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000

Related Devices (Code: DRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑