510(k) K832678

PHONATORY FUNCTION ANALYZER PS-77 by Kells Medical, Inc. — Product Code BXP

K832678 is an FDA 510(k) premarket notification submitted by Kells Medical, Inc. for the device "PHONATORY FUNCTION ANALYZER PS-77". The FDA issued a decision of Substantially Equivalent on March 7, 1984. The device falls under product code BXP (Transducer, Gas Flow), a Class I device regulated under 21 CFR 868.2885. Kells Medical, Inc. has at least 10 other 510(k) clearances on record.