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FDA 510(k)

AMBIO REMOTE HEALTH MONITORING SYSTEM

K-Number: K130676 · 2013-07-08

ApplicantArrayent Health, LLC D/B/A Ambio Health
Decision Date2013-07-08
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMBIO REMOTE HEALTH MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arrayent Health, LLC D/B/A Ambio Health. It received FDA 510(k) clearance on 2013-07-08 under 510(k) number K130676. 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 AMBIO REMOTE HEALTH MONITORING SYSTEM?

AMBIO REMOTE HEALTH MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-07-08. The listed applicant is Arrayent Health, LLC D/B/A Ambio Health. The 510(k) number is K130676.

When did AMBIO REMOTE HEALTH MONITORING SYSTEM receive FDA 510(k) clearance?

AMBIO REMOTE HEALTH MONITORING SYSTEM received FDA 510(k) clearance on 2013-07-08, under 510(k) number K130676.

Who is the listed applicant for AMBIO REMOTE HEALTH MONITORING SYSTEM?

The FDA 510(k) record lists Arrayent Health, LLC D/B/A Ambio Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMBIO REMOTE HEALTH MONITORING SYSTEM?

The FDA product code for AMBIO REMOTE HEALTH MONITORING SYSTEM 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

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

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