Esaote Europe B.V.
Carmel, IN, US
Esaote Europe B.V. appears in FDA device records in Carmel, IN. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Esaote Europe B.V. between 2006 and 2016. The busiest year on record is 2006, with 2. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161168 | MyLabSix Ultrasound System | IYN | Substantially Equivalent | |
| K141486 | MYLABSIX ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K101605 | MYLABONE ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K083882 | MYLABFIVE | IYN | Substantially Equivalent | |
| K070903 | MYLAB40 | ITX | Substantially Equivalent | |
| K062598 | IMT.LAB SOFTWARE | LLZ | Substantially Equivalent | |
| K061755 | MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM | IYO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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