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FDA 510(k)

Universal SmartECG

K-Number: K173952 · 2018-08-28

ApplicantVectracor, Inc.
Decision Date2018-08-28
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Universal SmartECG is the device name listed in this FDA 510(k) record. The listed applicant is Vectracor, Inc.. It received FDA 510(k) clearance on 2018-08-28 under 510(k) number K173952. 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 Universal SmartECG?

Universal SmartECG is a medical device that received FDA 510(k) clearance on 2018-08-28. The listed applicant is Vectracor, Inc.. The 510(k) number is K173952.

When did Universal SmartECG receive FDA 510(k) clearance?

Universal SmartECG received FDA 510(k) clearance on 2018-08-28, under 510(k) number K173952.

Who is the listed applicant for Universal SmartECG?

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

What is the FDA product code for Universal SmartECG?

The FDA product code for Universal SmartECG 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.

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