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FDA 510(k)

Servator B SALF Solution

K-Number: K180481 · 2018-06-29

ApplicantS.A.L.F. Spa
Decision Date2018-06-29
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Servator B SALF Solution is the device name listed in this FDA 510(k) record. The listed applicant is S.A.L.F. Spa. It received FDA 510(k) clearance on 2018-06-29 under 510(k) number K180481. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Servator B SALF Solution?

Servator B SALF Solution is a medical device that received FDA 510(k) clearance on 2018-06-29. The listed applicant is S.A.L.F. Spa. The 510(k) number is K180481.

When did Servator B SALF Solution receive FDA 510(k) clearance?

Servator B SALF Solution received FDA 510(k) clearance on 2018-06-29, under 510(k) number K180481.

Who is the listed applicant for Servator B SALF Solution?

The FDA 510(k) record lists S.A.L.F. Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Servator B SALF Solution?

The FDA product code for Servator B SALF Solution is KDN.

Other records listing S.A.L.F. Spa 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.

K230193Servator P Plus SALF SolutionK211842Servator M SALF SolutionK202652Servator P SALF Solution with THAMK190063Servator C SALF SolutionK170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags

Related Devices (Code: KDN)

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.

K261644Perfadex PlusXvivo Perfusion ABK260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc.K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO LifeK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges Lopez

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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