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510(k) Data Aggregation
K Number
K180242Device Name
HeRO Symphony, HeRO ES, HeRO solo/duet
Manufacturer
Date Cleared
2018-02-28
(30 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
Medical Predictive Science Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HeRO is intended to acquire, store, and report on ECG data collected from infants. HeRO is intended to be used under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment.
HeRO is intended to be used for the variability in RR intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HeRO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate.
HeRO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
The specialized HRV measurements produced by HeRO have not been approved by the FDA for any specific clinical diagnosis.
HeRO acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.
Device Description
HeRO Symphony, HeRO solo/duet, and HeRO ES are comprised of off-the-shelf Personal Computers (PC's) and special-purpose hardware capable of acquiring, storing, analyzing, and reporting ECG data from the cardiac monitoring real-time network. Data is acquired either on a special-purpose Data Acquisition Device (DAD) or via the physiological monitoring network. It is stored and analyzed on a HeRO Server or physiological monitor. Results of the analyses are reported on one or more Viewing Stations. The analysis algorithms identify Heart Rate Variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability.
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