510(k) K961090

AUTOMATIC VISUAL FIELD PLOTTER AP-125 by Kowa Optimed, Inc. — Product Code HPT

K961090 is an FDA 510(k) premarket notification submitted by Kowa Optimed, Inc. for the device "AUTOMATIC VISUAL FIELD PLOTTER AP-125". The FDA issued a decision of Substantially Equivalent on June 17, 1996. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1996
Date Received
March 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perimeter, Automatic, Ac-Powered
Device Class
Class I
Regulation Number
886.1605
Review Panel
OP
Submission Type