510(k) K011693

TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 by Trumpf Medical Systems, Inc. — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2001
Date Received
May 31, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type