510(k) K934509

PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER by Sdi Diagnostics, Inc. — Product Code CAH

K934509 is an FDA 510(k) premarket notification submitted by Sdi Diagnostics, Inc. for the device "PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER". The FDA issued a decision of Substantially Equivalent on October 21, 1993. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Sdi Diagnostics, Inc. has at least 9 other 510(k) clearances on record.