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FDA 510(k)

ECHONET

K-Number: K954860 · 1995-12-21

ApplicantHeartlab, Inc.
Decision Date1995-12-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHONET is the device name listed in this FDA 510(k) record. The listed applicant is Heartlab, Inc.. It received FDA 510(k) clearance on 1995-12-21 under 510(k) number K954860. 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 ECHONET?

ECHONET is a medical device that received FDA 510(k) clearance on 1995-12-21. The listed applicant is Heartlab, Inc.. The 510(k) number is K954860.

When did ECHONET receive FDA 510(k) clearance?

ECHONET received FDA 510(k) clearance on 1995-12-21, under 510(k) number K954860.

Who is the listed applicant for ECHONET?

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

What is the FDA product code for ECHONET?

The FDA product code for ECHONET is LLZ.

Related Clinical Trials

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Other records listing Heartlab, 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.

K050858ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEMK050228AGFA HEARTLAB CARDIOVASCULARK042042ULTRASOUND CAPTURE SYSTEMK040896MODIFICATION TO ENCOMPASSK954479DICOMVIEW

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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