FDA 510(k)

S-Line

K-Number: K213191 · 2022-05-24

Decision Date2022-05-24

Product CodeLGZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

S-Line is the device name listed in this FDA 510(k) record. The listed applicant is Barkey GmbH & Co. KG. It received FDA 510(k) clearance on 2022-05-24 under 510(k) number K213191. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-Line?

S-Line is a medical device that received FDA 510(k) clearance on 2022-05-24. The listed applicant is Barkey GmbH & Co. KG. The 510(k) number is K213191.

When did S-Line receive FDA 510(k) clearance?

S-Line received FDA 510(k) clearance on 2022-05-24, under 510(k) number K213191.

Who is the listed applicant for S-Line?

The FDA 510(k) record lists Barkey GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-Line?

The FDA product code for S-Line is LGZ.

Related Devices (Code: LGZ)

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.

K260988°M Warmer System with °M StationMequ A/S K252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/S K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.K211800Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid WarmerQuality IN Flow , Ltd.

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.