MAICO Diagnostics GmbH
Berlin, DE
MAICO Diagnostics GmbH appears in FDA device records in Berlin, DE. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for MAICO Diagnostics GmbH between 2001 and 2017. The busiest year on record is 2001, with 1. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2006 | 1 |
| 2009 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K171506 | Easyscreen | EWO | Substantially Equivalent | |
| K162210 | touchTymp | ETY | Substantially Equivalent | |
| K082035 | MAICO MB 11 WITH BERAPHONE PROBE | GWJ | Substantially Equivalent | |
| K060885 | MODEL MI 44 TYMPANOMETER | EWO | Substantially Equivalent | |
| K003913 | HINT AUDIOMETER, OR HINT | EWO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002504821 | 3002504821 | MAICO Diagnostics GmbH | Sickingenstr. 70-71, Berlin 10553 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain