510(k) K972614

TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605 by Healthdyne Technologies, Inc. — Product Code CAW

K972614 is an FDA 510(k) premarket notification submitted by Healthdyne Technologies, Inc. for the device "TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605". The FDA issued a decision of Substantially Equivalent on January 20, 1998. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Healthdyne Technologies, Inc. has at least 8 other 510(k) clearances on record.