510(k) K851560

PORTASPIR II by Roseburg SA — Product Code BTA

K851560 is an FDA 510(k) premarket notification submitted by Roseburg SA for the device "PORTASPIR II". The FDA issued a decision of Substantially Equivalent on December 13, 1985. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Roseburg SA has at least 10 other 510(k) clearances on record.