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FDA 510(k)

Liba3 System

K-Number: K182532 · 2019-05-15

ApplicantNational Cardiac, Inc.
Decision Date2019-05-15
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Liba3 System is the device name listed in this FDA 510(k) record. The listed applicant is National Cardiac, Inc.. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K182532. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Liba3 System?

Liba3 System is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is National Cardiac, Inc.. The 510(k) number is K182532.

When did Liba3 System receive FDA 510(k) clearance?

Liba3 System received FDA 510(k) clearance on 2019-05-15, under 510(k) number K182532.

Who is the listed applicant for Liba3 System?

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

What is the FDA product code for Liba3 System?

The FDA product code for Liba3 System is DSI.

Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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