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FDA 510(k)

ERBE MODEL VIO 300 D WITH ACCESSORIES

K-Number: K083452 · 2008-12-31

ApplicantErbe USA, Inc.
Decision Date2008-12-31
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERBE MODEL VIO 300 D 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 2008-12-31 under 510(k) number K083452. 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 MODEL VIO 300 D WITH ACCESSORIES?

ERBE MODEL VIO 300 D WITH ACCESSORIES is a medical device that received FDA 510(k) clearance on 2008-12-31. The listed applicant is Erbe USA, Inc.. The 510(k) number is K083452.

When did ERBE MODEL VIO 300 D WITH ACCESSORIES receive FDA 510(k) clearance?

ERBE MODEL VIO 300 D WITH ACCESSORIES received FDA 510(k) clearance on 2008-12-31, under 510(k) number K083452.

Who is the listed applicant for ERBE MODEL VIO 300 D 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 MODEL VIO 300 D WITH ACCESSORIES?

The FDA product code for ERBE MODEL VIO 300 D WITH ACCESSORIES is GEI.

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Official Source

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