510(k) K881004

OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR by Keymed, Inc. — Product Code FCX

K881004 is an FDA 510(k) premarket notification submitted by Keymed, Inc. for the device "OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR". The FDA issued a decision of Substantially Equivalent on May 12, 1988. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. Keymed, Inc. has at least 10 other 510(k) clearances on record.