510(k) K992606

CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 by Canon USA, Inc. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2000
Date Received
August 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type