Submission Details
| 510(k) Number | K162210 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 05, 2016 |
| Decision Date | November 16, 2016 |
| Days to Decision | 103 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Special
touchTymp
Nov 2016
Decision
103d
Days
Class 2
Risk
About This 510(k) Submission
K162210 is an FDA 510(k) clearance for the touchTymp, a Tester, Auditory Impedance (Class II — Special Controls, product code ETY), submitted by Maico Diagnostics GmbH (Berlin, DE). The FDA issued a Cleared decision on November 16, 2016, 103 days after receiving the submission on August 5, 2016. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.
Device Classification
| Product Code | ETY — Tester, Auditory Impedance |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.1090 |
Manufacturer
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