HeRO Symphony, HeRO ES, HeRO solo/duet
K-Number: K180242 · 2018-02-28
Decision Date2018-02-28
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
HeRO Symphony, HeRO ES, HeRO solo/duet is a medical device manufactured by Medical Predictive Science Corporation. It received FDA 510(k) clearance on 2018-02-28 under approval number K180242. 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 HeRO Symphony, HeRO ES, HeRO solo/duet?
HeRO Symphony, HeRO ES, HeRO solo/duet is a medical device that received FDA 510(k) clearance on 2018-02-28. It is manufactured by Medical Predictive Science Corporation. The 510(k) number is K180242.
When was HeRO Symphony, HeRO ES, HeRO solo/duet approved by the FDA?
HeRO Symphony, HeRO ES, HeRO solo/duet received FDA 510(k) clearance on 2018-02-28, under approval number K180242.
What company makes HeRO Symphony, HeRO ES, HeRO solo/duet?
HeRO Symphony, HeRO ES, HeRO solo/duet is manufactured by Medical Predictive Science Corporation.
What is the FDA product code for HeRO Symphony, HeRO ES, HeRO solo/duet?
The FDA product code for HeRO Symphony, HeRO ES, HeRO solo/duet 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.