General Medical Merate S.p.A.
SERIATE, BERGAMO Bergamo, IT
GENERAL MEDICAL MERATE S.P.A. appears in FDA device records in SERIATE, BERGAMO Bergamo, IT. FDA records list 7 510(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 7 510(k) clearances for General Medical Merate S.p.A. between 1982 and 2021. The busiest year on record is 1982, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1988 | 1 |
| 2004 | 1 |
| 2008 | 1 |
| 2014 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213081 | CLISIS SYSTEMS, Discovery RF180 | IZF | Substantially Equivalent | |
| K173395 | MECALL CLISIS SYSTEMS, Discovery RF180 | JAA | Substantially Equivalent | |
| K140380 | OPERA SWING | JAA | Substantially Equivalent | |
| K082243 | PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS | OWB | Substantially Equivalent | |
| K041605 | PRECISION RXI ANALOG X-RAY SYSTEM | OWB | Substantially Equivalent | |
| K881386 | X-RAY GENERATING SYSTEM TF 1000 | IZO | Substantially Equivalent | |
| K827993 | MTH C/A MOBILE C ARM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8020997 | 3002807092 | GENERAL MEDICAL MERATE S.P.A. | VIA PARTIGIANI, 25, SERIATE, BERGAMO 24068 IT | 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