510(k) K873614

CBG CUFF MANOMETER by Bio-Med Devices, Inc. — Product Code BSK

K873614 is an FDA 510(k) premarket notification submitted by Bio-Med Devices, Inc. for the device "CBG CUFF MANOMETER". The FDA issued a decision of Substantially Equivalent on January 22, 1988. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Bio-Med Devices, Inc. has at least 10 other 510(k) clearances on record.