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FDA 510(k)

TelePatch Cardiac Monitor

K-Number: K161916 · 2016-12-21

ApplicantMedicomp, Inc.
Decision Date2016-12-21
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TelePatch Cardiac Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K161916. 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 TelePatch Cardiac Monitor?

TelePatch Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Medicomp, Inc.. The 510(k) number is K161916.

When did TelePatch Cardiac Monitor receive FDA 510(k) clearance?

TelePatch Cardiac Monitor received FDA 510(k) clearance on 2016-12-21, under 510(k) number K161916.

Who is the listed applicant for TelePatch Cardiac Monitor?

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

What is the FDA product code for TelePatch Cardiac Monitor?

The FDA product code for TelePatch Cardiac Monitor is DRG.

Other records listing Medicomp, 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.

K173170Epicardia Anywhere

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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