510(k) K002686

ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E by Nellcor Puritan Bennett, Inc. — Product Code CBK

K002686 is an FDA 510(k) premarket notification submitted by Nellcor Puritan Bennett, Inc. for the device "ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E". The FDA issued a decision of ST on October 18, 2000. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Nellcor Puritan Bennett, Inc. has at least 10 other 510(k) clearances on record.