510(k) K910138

TVS II ELECTRONIC INCENTIVE SPIROMETER by Monaghan Medical Corp. — Product Code BWF

K910138 is an FDA 510(k) premarket notification submitted by Monaghan Medical Corp. for the device "TVS II ELECTRONIC INCENTIVE SPIROMETER". The FDA issued a decision of Substantially Equivalent on March 12, 1991. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Monaghan Medical Corp. has at least 10 other 510(k) clearances on record.