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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 the device name listed in this FDA 510(k) record. The listed applicant is Bowa-Electronics GmbH & Co. KG. It received FDA 510(k) clearance on 2020-04-02 under 510(k) 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. The listed applicant is Bowa-Electronics GmbH & Co. KG. The 510(k) number is K193591.

When did ARC 400 receive FDA 510(k) clearance?

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

Who is the listed applicant for ARC 400?

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

What is the FDA product code for ARC 400?

The FDA product code for ARC 400 is GEI.

Other records listing Bowa-Electronics GmbH & Co. KG 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.

K173877BOWA Neutral Electrodes

Related Devices (Code: GEI)

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.

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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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