510(k) K915369

THE EQUALIZER by Advanced Rehabilitative Technology, Inc. — Product Code IKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1993
Date Received
November 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Miniature Pressure
Device Class
Class I
Regulation Number
890.1615
Review Panel
PM
Submission Type