touchTymp— 510(k) K162210

Substantially Equivalent

Maico Diagnostics GmbH

FDA 510(k) clearance K162210 for touchTymp, Substantially Equivalent on 2016-11-16. Applicant: Maico Diagnostics GmbH. Device class: 2.

Clearance details

Applicant: Maico Diagnostics GmbH
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 2016-08-05
Decision date: 2016-11-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Berlin, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code ETY

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K151616 — AT2352015-07-15
K151509 — GSI TympStar Pro Middle Ear Analyzer2015-06-25

More clearances from Maico Diagnostics GmbH

K171506 — Easyscreen2017-08-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.