CardioBand ECG Event Recorder
K-Number: K181998 · 2018-11-15
Decision Date2018-11-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CardioBand ECG Event Recorder is a medical device manufactured by Samsung Strategy and Innovation Center (Ssic). It received FDA 510(k) clearance on 2018-11-15 under approval number K181998. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CardioBand ECG Event Recorder?
CardioBand ECG Event Recorder is a medical device that received FDA 510(k) clearance on 2018-11-15. It is manufactured by Samsung Strategy and Innovation Center (Ssic). The 510(k) number is K181998.
When was CardioBand ECG Event Recorder approved by the FDA?
CardioBand ECG Event Recorder received FDA 510(k) clearance on 2018-11-15, under approval number K181998.
What company makes CardioBand ECG Event Recorder?
CardioBand ECG Event Recorder is manufactured by Samsung Strategy and Innovation Center (Ssic).
What is the FDA product code for CardioBand ECG Event Recorder?
The FDA product code for CardioBand ECG Event Recorder is DPS.
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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.