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FDA 510(k)

ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR

K-Number: K110390 · 2011-07-29

ApplicantHandelshaus Dittman GmbH
Decision Date2011-07-29
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR is the device name listed in this FDA 510(k) record. The listed applicant is Handelshaus Dittman GmbH. It received FDA 510(k) clearance on 2011-07-29 under 510(k) number K110390. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR?

ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR is a medical device that received FDA 510(k) clearance on 2011-07-29. The listed applicant is Handelshaus Dittman GmbH. The 510(k) number is K110390.

When did ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR receive FDA 510(k) clearance?

ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR received FDA 510(k) clearance on 2011-07-29, under 510(k) number K110390.

Who is the listed applicant for ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR?

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

What is the FDA product code for ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR?

The FDA product code for ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR is GZJ.

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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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