510(k) K030985

BREAS PV 10I CPAP SYSTEM, MODEL PV 10I by Vital Signs, Inc. — Product Code BZD

K030985 is an FDA 510(k) premarket notification submitted by Vital Signs, Inc. for the device "BREAS PV 10I CPAP SYSTEM, MODEL PV 10I". The FDA issued a decision of Substantially Equivalent on October 15, 2003. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Vital Signs, Inc. has at least 10 other 510(k) clearances on record.