510(k) K955047

WESTMED CIRCULARIE PEP DEVICES by Westmed Intl. — Product Code BYE

K955047 is an FDA 510(k) premarket notification submitted by Westmed Intl. for the device "WESTMED CIRCULARIE PEP DEVICES". The FDA issued a decision of Substantially Equivalent on March 27, 1996. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Westmed Intl. has at least 8 other 510(k) clearances on record.