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FDA 510(k)

S-Line

K-Number: K213191 · 2022-05-24

ApplicantBarkey GmbH & Co. KG
Decision Date2022-05-24
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

S-Line is a medical device manufactured by Barkey GmbH & Co. KG. It received FDA 510(k) clearance on 2022-05-24 under approval 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. It is manufactured by Barkey GmbH & Co. KG. The 510(k) number is K213191.

When was S-Line approved by the FDA?

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

What company makes S-Line?

S-Line is manufactured by Barkey GmbH & Co. KG.

What is the FDA product code for S-Line?

The FDA product code for S-Line is LGZ.

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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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