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FDA 510(k)

VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI

K-Number: K102378 · 2011-11-02

ApplicantVectracor, Inc.
Decision Date2011-11-02
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI is the device name listed in this FDA 510(k) record. The listed applicant is Vectracor, Inc.. It received FDA 510(k) clearance on 2011-11-02 under 510(k) number K102378. 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 VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI?

VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI is a medical device that received FDA 510(k) clearance on 2011-11-02. The listed applicant is Vectracor, Inc.. The 510(k) number is K102378.

When did VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI receive FDA 510(k) clearance?

VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI received FDA 510(k) clearance on 2011-11-02, under 510(k) number K102378.

Who is the listed applicant for VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI?

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 VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI?

The FDA product code for VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI is DPS.

Related Clinical Trials

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.

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Other records listing Vectracor, Inc. as applicant

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.

K173952Universal SmartECG

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.

K254255S-Patch CardioAIWellysis Corp.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 Commercial

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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