510(k) K011344

INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 by Collins Medical, Inc. — Product Code BZC

K011344 is an FDA 510(k) premarket notification submitted by Collins Medical, Inc. for the device "INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400". The FDA issued a decision of Substantially Equivalent on May 17, 2002. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Collins Medical, Inc. has at least 3 other 510(k) clearances on record.