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FDA 510(k)

HEALTH BUDDY APPLIANCE

K-Number: K050567 · 2005-04-05

ApplicantHealth Hero Network, Inc.
Decision Date2005-04-05
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEALTH BUDDY APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Health Hero Network, Inc.. It received FDA 510(k) clearance on 2005-04-05 under 510(k) number K050567. 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 HEALTH BUDDY APPLIANCE?

HEALTH BUDDY APPLIANCE is a medical device that received FDA 510(k) clearance on 2005-04-05. The listed applicant is Health Hero Network, Inc.. The 510(k) number is K050567.

When did HEALTH BUDDY APPLIANCE receive FDA 510(k) clearance?

HEALTH BUDDY APPLIANCE received FDA 510(k) clearance on 2005-04-05, under 510(k) number K050567.

Who is the listed applicant for HEALTH BUDDY APPLIANCE?

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

What is the FDA product code for HEALTH BUDDY APPLIANCE?

The FDA product code for HEALTH BUDDY APPLIANCE is DRG.

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Other records listing Health Hero Network, Inc. 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.

K080091MODIFICATION TO:HEALTH BUDDY APPLIANCEK070543MODIFICATION TO HEALTH BUDDY APPLIANCEK063612MODIFICATION TO HEALTH BUDDY APPLIANCEK060843MODIFICATION TO HEALTH BUDDY APPLIANCEK042273MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITYK040086HEALTH BUDDY WITH BUDDYLINK

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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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