510(k) K190985

BAROnova Insufflation System, BAROnova Accessory Kit by Baronova, Inc. — Product Code FCX

K190985 is an FDA 510(k) premarket notification submitted by Baronova, Inc. for the device "BAROnova Insufflation System, BAROnova Accessory Kit". The FDA issued a decision of Substantially Equivalent (kit) on May 14, 2019. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. Baronova, Inc. has at least 2 other 510(k) clearances on record.