The following data is part of a premarket notification filed by Maico Diagnostics Gmbh with the FDA for Touchtymp.
| Device ID | K162210 |
| 510k Number | K162210 |
| Device Name: | TouchTymp |
| Classification | Tester, Auditory Impedance |
| Applicant | MAICO DIAGNOSTICS GMBH SICKINGENSTR. 70-71 Berlin, DE 10553 |
| Contact | Uwe Ledworuski |
| Correspondent | Uwe Ledworuski MAICO DIAGNOSTICS GMBH SICKINGENSTR. 70-71 Berlin, DE 10553 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-05 |
| Decision Date | 2016-11-16 |
| Summary: | summary |