510(k) K971273

INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF by Bio-Tek Instruments, Inc. — Product Code DQA

K971273 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF". The FDA issued a decision of Substantially Equivalent on October 8, 1997. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Bio-Tek Instruments, Inc. has at least 10 other 510(k) clearances on record.