510(k) K802800

NARCO AIR-SHEILDS SYS. 100 MONITOR SYS by Narco Air-Shields — Product Code DXG

K802800 is an FDA 510(k) premarket notification submitted by Narco Air-Shields for the device "NARCO AIR-SHEILDS SYS. 100 MONITOR SYS". The FDA issued a decision of Substantially Equivalent on November 24, 1980. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Narco Air-Shields has at least 10 other 510(k) clearances on record.