510(k) K890268

PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION by Biomedical Dynamics, Inc. — Product Code KPE

K890268 is an FDA 510(k) premarket notification submitted by Biomedical Dynamics, Inc. for the device "PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION". The FDA issued a decision of Substantially Equivalent on May 5, 1989. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Biomedical Dynamics, Inc. has at least 9 other 510(k) clearances on record.