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FDA 510(k)

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM

K-Number: K112559 · 2011-12-02

ApplicantMedapps, Inc.
Decision Date2011-12-02
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medapps, Inc.. It received FDA 510(k) clearance on 2011-12-02 under 510(k) number K112559. 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 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM?

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-02. The listed applicant is Medapps, Inc.. The 510(k) number is K112559.

When did MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM receive FDA 510(k) clearance?

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM received FDA 510(k) clearance on 2011-12-02, under 510(k) number K112559.

Who is the listed applicant for MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM?

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

What is the FDA product code for MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM?

The FDA product code for MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM 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 Medapps, 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.

K083862MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEMK062377MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100

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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