FDA 510(k)

touchTymp

K-Number: K162210 · 2016-11-16

Decision Date2016-11-16

Product CodeETY

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

touchTymp is the device name listed in this FDA 510(k) record. The listed applicant is Maico Diagnostics GmbH. It received FDA 510(k) clearance on 2016-11-16 under 510(k) number K162210. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the touchTymp?

touchTymp is a medical device that received FDA 510(k) clearance on 2016-11-16. The listed applicant is Maico Diagnostics GmbH. The 510(k) number is K162210.

When did touchTymp receive FDA 510(k) clearance?

touchTymp received FDA 510(k) clearance on 2016-11-16, under 510(k) number K162210.

Who is the listed applicant for touchTymp?

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

What is the FDA product code for touchTymp?

The FDA product code for touchTymp is ETY.

Other records listing Maico Diagnostics GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171506Easyscreen

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Official Source

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