510(k) K193068

AIROS 8 Sequential Compression Device by Airos Medical, Inc. — Product Code JOW

K193068 is an FDA 510(k) premarket notification submitted by Airos Medical, Inc. for the device "AIROS 8 Sequential Compression Device". The FDA issued a decision of Substantially Equivalent on December 4, 2019. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Airos Medical, Inc. has at least 6 other 510(k) clearances on record.