510(k) K905373

MINIATURE TEMPERATURE TRAINER MODEL DT-002 by Bio-Feedback Systems, Inc. — Product Code HCC

K905373 is an FDA 510(k) premarket notification submitted by Bio-Feedback Systems, Inc. for the device "MINIATURE TEMPERATURE TRAINER MODEL DT-002". The FDA issued a decision of Substantially Equivalent on April 10, 1991. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Bio-Feedback Systems, Inc. has at least 10 other 510(k) clearances on record.