Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K113607
BIOPSY DIGIT S BIOPSY SL · Giotto USA, LLC · decided 2012-08-10 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| BIOPSY DIGIT | BIOPSY DIGIT SL | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL | IZH | 08033837190202 |
| BIOPSY DIGIT | BIOPSY DIGIT SL | IMS GIOTTO SPA | MUE | 08056977360090 |