510(k) K973756

EYE SYS VISTA by Eyesys Technologies, Inc. — Product Code HLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1997
Date Received
October 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoscope, Ac-Powered
Device Class
Class I
Regulation Number
886.1350
Review Panel
OP
Submission Type