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FDA 510(k)

ERBE ESU Model VIO dV with Accessories

K-Number: K150364 · 2016-05-05

ApplicantErbe Elektromedizin GmbH
Decision Date2016-05-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERBE ESU Model VIO dV with Accessories 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 2016-05-05 under 510(k) number K150364. 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 ESU Model VIO dV with Accessories?

ERBE ESU Model VIO dV with Accessories is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K150364.

When did ERBE ESU Model VIO dV with Accessories receive FDA 510(k) clearance?

ERBE ESU Model VIO dV with Accessories received FDA 510(k) clearance on 2016-05-05, under 510(k) number K150364.

Who is the listed applicant for ERBE ESU Model VIO dV with Accessories?

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 ESU Model VIO dV with Accessories?

The FDA product code for ERBE ESU Model VIO dV with Accessories is GEI.

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Official Source

View on FDA Database →

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