510(k) K933611

THE BTE WS30 by Baltimore Therapeutic Equipment Co. — Product Code ISD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1994
Date Received
July 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type