510(k) K942155

HMT ENDOSCREEN, MODEL ESC 501 by Servicetrends, Inc. — Product Code FCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1994
Date Received
May 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type