Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K112041
KOO SMALL VOLUME NEBULIZER (SVN) · Koo (Shanghai) Industries Co., Ltd. · decided 2011-12-22 (SESE)
FDA 510(k) database ↗Summary PDF ↗
No GUDID device is registered under this submission yet — registration typically lags clearance by months.
Devices
No matching devices.
Check the spelling, try the All scope, or search by brand, company, UDI barcode, or 3-letter product code.