510(k) K823273

BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. by Bentley Laboratories, Inc. — Product Code DTZ

K823273 is an FDA 510(k) premarket notification submitted by Bentley Laboratories, Inc. for the device "BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.". The FDA issued a decision of Substantially Equivalent on January 5, 1983. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Bentley Laboratories, Inc. has at least 10 other 510(k) clearances on record.