510(k) K954492

MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX by Mercury Medical — Product Code BWF

K954492 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX". The FDA issued a decision of Substantially Equivalent on Oct 21, 1996. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Mercury Medical has at least 10 other 510(k) clearances on record.