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FDA 510(k)

EchoMD Automated Ejection Fraction Software

K-Number: K173780 · 2018-06-14

ApplicantBay Labs, Inc.
Decision Date2018-06-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoMD Automated Ejection Fraction Software is the device name listed in this FDA 510(k) record. The listed applicant is Bay Labs, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K173780. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EchoMD Automated Ejection Fraction Software?

EchoMD Automated Ejection Fraction Software is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Bay Labs, Inc.. The 510(k) number is K173780.

When did EchoMD Automated Ejection Fraction Software receive FDA 510(k) clearance?

EchoMD Automated Ejection Fraction Software received FDA 510(k) clearance on 2018-06-14, under 510(k) number K173780.

Who is the listed applicant for EchoMD Automated Ejection Fraction Software?

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

What is the FDA product code for EchoMD Automated Ejection Fraction Software?

The FDA product code for EchoMD Automated Ejection Fraction Software is LLZ.

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.

NCT027999793D Imaging: Prognostic Role in Pulmonary Arterial HypertensionCOMPLETEDNCT06699056AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable MonitorRECRUITINGNCT07688863Comparative Effects of Different Inspiratory Muscle Training Modalities in Patients With Heart Failure.ENROLLING_BY_INVITATION

Related Devices (Code: LLZ)

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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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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