510(k) K953055

MISTASSIST BREATHING EXERCISER by The Merlin Corp. — Product Code BWF

K953055 is an FDA 510(k) premarket notification submitted by The Merlin Corp. for the device "MISTASSIST BREATHING EXERCISER". The FDA issued a decision of Substantially Equivalent on February 8, 1996. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. The Merlin Corp. has at least 1 other 510(k) clearance on record.