510(k) K993668

LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 by Laerdal Medical A/S — Product Code BTA

K993668 is an FDA 510(k) premarket notification submitted by Laerdal Medical A/S for the device "LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20". The FDA issued a decision of Substantially Equivalent on December 20, 1999. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Laerdal Medical A/S has at least 10 other 510(k) clearances on record.