510(k) K901513

NIDEK RT-1200S (MARCO TRS-1200) by Nidek, Inc. — Product Code HKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1990
Date Received
March 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractometer, Ophthalmic
Device Class
Class I
Regulation Number
886.1760
Review Panel
OP
Submission Type