510(k) K945382

TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER by Expertech Assoc., Inc. — Product Code HLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1995
Date Received
November 2, 1994
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