FDA 510(k)

smart-sync

K-Number: K212271 · 2022-02-04

Decision Date2022-02-04

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

smart-sync is the device name listed in this FDA 510(k) record. The listed applicant is Northh Medical GmbH. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K212271. 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 smart-sync?

smart-sync is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Northh Medical GmbH. The 510(k) number is K212271.

When did smart-sync receive FDA 510(k) clearance?

smart-sync received FDA 510(k) clearance on 2022-02-04, under 510(k) number K212271.

Who is the listed applicant for smart-sync?

The FDA 510(k) record lists Northh Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for smart-sync?

The FDA product code for smart-sync is LNH.

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 Systems K261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG K260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm Corporation K260746S-scan Open (100001800)Esaote, S.p.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.