510(k) K971501

SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER by Bio-Logic Systems Corp. — Product Code MNR

K971501 is an FDA 510(k) premarket notification submitted by Bio-Logic Systems Corp. for the device "SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER". The FDA issued a decision of Substantially Equivalent on October 14, 1997. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Bio-Logic Systems Corp. has at least 10 other 510(k) clearances on record.