touchTymp

FDA 510(k) K162210 · Maico Diagnostics GmbH

Substantially Equivalent

510(k) numberK162210

Submission

Device name
touchTymp
Applicant
Maico Diagnostics GmbH
Berlin, DE
Received
August 5, 2016
Decision date
November 16, 2016
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ETY – Tester, Auditory Impedance
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1090
Specialty
Ear, Nose, Throat

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Questions and answers

When was touchTymp cleared by the FDA?

touchTymp (K162210) received a 510(k) decision of Substantially Equivalent on November 16, 2016, 103 days after the submission was received.

What is the product code of K162210?

The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.