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FDA 510(k)

MRI ECG Patient Cable

K-Number: K192852 · 2020-03-28

ApplicantIvy Biomedical Systems, Inc.
Decision Date2020-03-28
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRI ECG Patient Cable is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2020-03-28 under 510(k) number K192852. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRI ECG Patient Cable?

MRI ECG Patient Cable is a medical device that received FDA 510(k) clearance on 2020-03-28. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K192852.

When did MRI ECG Patient Cable receive FDA 510(k) clearance?

MRI ECG Patient Cable received FDA 510(k) clearance on 2020-03-28, under 510(k) number K192852.

Who is the listed applicant for MRI ECG Patient Cable?

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

What is the FDA product code for MRI ECG Patient Cable?

The FDA product code for MRI ECG Patient Cable is LNH.

Other records listing Ivy Biomedical Systems, Inc. as applicant

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Related Devices (Code: LNH)

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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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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