510(k) K952691

WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT by Welch Allyn, Inc. — Product Code FJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1995
Date Received
June 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Blood Level
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type