510(k) K880923

PATIENT VENTILATOR ISOLATOR by Dryden Corp. — Product Code CBK

K880923 is an FDA 510(k) premarket notification submitted by Dryden Corp. for the device "PATIENT VENTILATOR ISOLATOR". The FDA issued a decision of Substantially Equivalent on September 6, 1988. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Dryden Corp. has at least 10 other 510(k) clearances on record.