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 a medical device manufactured by Synergen Technology Labs, LLC. It received FDA 510(k) clearance on 2018-05-30 under approval 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. It is manufactured by Synergen Technology Labs, LLC. The 510(k) number is K171019.
When was ScioCardio ECG Transmitter approved by the FDA?
ScioCardio ECG Transmitter received FDA 510(k) clearance on 2018-05-30, under approval number K171019.
What company makes ScioCardio ECG Transmitter?
ScioCardio ECG Transmitter is manufactured by Synergen Technology Labs, LLC.
What is the FDA product code for ScioCardio ECG Transmitter?
The FDA product code for ScioCardio ECG Transmitter is DRG.
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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.