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FDA 510(k)

Erbe APCapplicators

K-Number: K183445 · 2019-04-04

ApplicantErbe Elektromedizin GmbH
Decision Date2019-04-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Erbe APCapplicators is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2019-04-04 under 510(k) number K183445. 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 Erbe APCapplicators?

Erbe APCapplicators is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K183445.

When did Erbe APCapplicators receive FDA 510(k) clearance?

Erbe APCapplicators received FDA 510(k) clearance on 2019-04-04, under 510(k) number K183445.

Who is the listed applicant for Erbe APCapplicators?

The FDA 510(k) record lists Erbe Elektromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Erbe APCapplicators?

The FDA product code for Erbe APCapplicators is GEI.

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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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