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FDA 510(k)

ERBE ESU MODEL VIO DV WITH ACCESSORIES

K-Number: K133180 · 2013-12-11

ApplicantErbe USA, Inc.
Decision Date2013-12-11
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 USA, Inc.. It received FDA 510(k) clearance on 2013-12-11 under 510(k) number K133180. 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 2013-12-11. The listed applicant is Erbe USA, Inc.. The 510(k) number is K133180.

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 2013-12-11, under 510(k) number K133180.

Who is the listed applicant for ERBE ESU MODEL VIO DV WITH ACCESSORIES?

The FDA 510(k) record lists Erbe USA, Inc. 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

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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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