510(k) K022103

PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM by Puritan Bennett Corp. — Product Code BZG

K022103 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 27, 2002. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.