510(k) K141522

APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES by Apex Medical Corp. — Product Code BZD

K141522 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES". The FDA issued a decision of Substantially Equivalent on October 6, 2014. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Apex Medical Corp. has at least 10 other 510(k) clearances on record.