510(k) K102192

INDISCAL DIGITAL MANOMETER by Baylis Medical Co., Inc. — Product Code FMF

K102192 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "INDISCAL DIGITAL MANOMETER". The FDA issued a decision of Substantially Equivalent on February 23, 2011. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.