MCUBE TECHNOLOGY Co.,Ltd.
Seoul, KR
MCUBE TECHNOLOGY Co.,Ltd. appears in FDA device records in Seoul, KR. FDA records list 6 510(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 6 510(k) clearances for MCUBE TECHNOLOGY Co.,Ltd. between 2009 and 2020. The busiest year on record is 2020, with 3. The most recent is 2020, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2011 | 1 |
| 2017 | 1 |
| 2020 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201995 | CUBEScan BioCon-1100 | IYO | Substantially Equivalent | |
| K200749 | CUBEScan BioCon-900S | IYO | Substantially Equivalent | |
| K200548 | CUBEScan BioCon-1100 | IYO | Substantially Equivalent | |
| K171591 | CUBEScan™ BioCon-900 (Bladder Volume Measurement System) | IYO | Substantially Equivalent | |
| K111021 | CUBESCAN / BIOCON-700 | ITX | Substantially Equivalent | |
| K091518 | CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007740628 | 3007740628 | MCUBE TECHNOLOGY Co.,Ltd. | 39,Magokjungang 12-ro, Gangseo-gu, Seoul 07789 KR | 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