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FDA 510(k)

ScioCardio ECG Transmitter

K-Number: K171019 · 2018-05-30

ApplicantSynergen Technology Labs, LLC
Decision Date2018-05-30
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ScioCardio ECG Transmitter is the device name listed in this FDA 510(k) record. The listed applicant is Synergen Technology Labs, LLC. It received FDA 510(k) clearance on 2018-05-30 under 510(k) number K171019. 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 ScioCardio ECG Transmitter?

ScioCardio ECG Transmitter is a medical device that received FDA 510(k) clearance on 2018-05-30. The listed applicant is Synergen Technology Labs, LLC. The 510(k) number is K171019.

When did ScioCardio ECG Transmitter receive FDA 510(k) clearance?

ScioCardio ECG Transmitter received FDA 510(k) clearance on 2018-05-30, under 510(k) number K171019.

Who is the listed applicant for ScioCardio ECG Transmitter?

The FDA 510(k) record lists Synergen Technology Labs, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ScioCardio ECG Transmitter?

The FDA product code for ScioCardio ECG Transmitter is DRG.

Other records listing Synergen Technology Labs, LLC 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.

K252978ScioCardio ECG Analysis Platform

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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