510(k) K821107

EXOPHTHALMOMETER by Medical Equipment Designs, Inc. — Product Code HCS

K821107 is an FDA 510(k) premarket notification submitted by Medical Equipment Designs, Inc. for the device "EXOPHTHALMOMETER". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code HCS (Device, Temperature Measurement, Direct Contact, Powered), a Class II device regulated under 21 CFR 882.1570. Medical Equipment Designs, Inc. has at least 10 other 510(k) clearances on record.