510(k) K936209

SLIT LAMP, H-201 by Canon USA, Inc. — Product Code HJO

K936209 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "SLIT LAMP, H-201". The FDA issued a decision of Substantially Equivalent on April 1, 1994. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Canon USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1994
Date Received
December 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type