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FDA 510(k)

PATIENT DATA HANDLER & DEVICES (PDH&D)

K-Number: K063484 · 2006-12-22

ApplicantIntermed Advisors, Inc.
Decision Date2006-12-22
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PATIENT DATA HANDLER & DEVICES (PDH&D) is the device name listed in this FDA 510(k) record. The listed applicant is Intermed Advisors, Inc.. It received FDA 510(k) clearance on 2006-12-22 under 510(k) number K063484. 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 PATIENT DATA HANDLER & DEVICES (PDH&D)?

PATIENT DATA HANDLER & DEVICES (PDH&D) is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Intermed Advisors, Inc.. The 510(k) number is K063484.

When did PATIENT DATA HANDLER & DEVICES (PDH&D) receive FDA 510(k) clearance?

PATIENT DATA HANDLER & DEVICES (PDH&D) received FDA 510(k) clearance on 2006-12-22, under 510(k) number K063484.

Who is the listed applicant for PATIENT DATA HANDLER & DEVICES (PDH&D)?

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

What is the FDA product code for PATIENT DATA HANDLER & DEVICES (PDH&D)?

The FDA product code for PATIENT DATA HANDLER & DEVICES (PDH&D) is DRG.

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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.

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