510(k) K863312

SANDHILL AMS by Sandhill — Product Code FAP

K863312 is an FDA 510(k) premarket notification submitted by Sandhill for the device "SANDHILL AMS". The FDA issued a decision of Substantially Equivalent on December 3, 1986. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Sandhill has at least 2 other 510(k) clearances on record.