510(k) K881219

AUTOMATIC PERIMETER, AP-340 by Kowa Optimed, Inc. — Product Code HPT

K881219 is an FDA 510(k) premarket notification submitted by Kowa Optimed, Inc. for the device "AUTOMATIC PERIMETER, AP-340". The FDA issued a decision of Substantially Equivalent on May 3, 1988. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Kowa Optimed, Inc. has at least 9 other 510(k) clearances on record.