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FDA 510(k)

ARC 400

K-Number: K193591 · 2020-04-02

ApplicantBowa-Electronics GmbH & Co. KG
Decision Date2020-04-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARC 400 is a medical device manufactured by Bowa-Electronics GmbH & Co. KG. It received FDA 510(k) clearance on 2020-04-02 under approval number K193591. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARC 400?

ARC 400 is a medical device that received FDA 510(k) clearance on 2020-04-02. It is manufactured by Bowa-Electronics GmbH & Co. KG. The 510(k) number is K193591.

When was ARC 400 approved by the FDA?

ARC 400 received FDA 510(k) clearance on 2020-04-02, under approval number K193591.

What company makes ARC 400?

ARC 400 is manufactured by Bowa-Electronics GmbH & Co. KG.

What is the FDA product code for ARC 400?

The FDA product code for ARC 400 is GEI.

Other Devices by Bowa-Electronics GmbH & Co. KG

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Official Source

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