Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CardioFlux with Faraday Analytical Cloud

K-Number: K182571 · 2019-03-15

ApplicantGenetesis, Inc.
Decision Date2019-03-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardioFlux with Faraday Analytical Cloud is the device name listed in this FDA 510(k) record. The listed applicant is Genetesis, Inc.. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K182571. 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 CardioFlux with Faraday Analytical Cloud?

CardioFlux with Faraday Analytical Cloud is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Genetesis, Inc.. The 510(k) number is K182571.

When did CardioFlux with Faraday Analytical Cloud receive FDA 510(k) clearance?

CardioFlux with Faraday Analytical Cloud received FDA 510(k) clearance on 2019-03-15, under 510(k) number K182571.

Who is the listed applicant for CardioFlux with Faraday Analytical Cloud?

The FDA 510(k) record lists Genetesis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CardioFlux with Faraday Analytical Cloud?

The FDA product code for CardioFlux with Faraday Analytical Cloud is DPS.

Related Devices (Code: DPS)

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.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, 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.

↑