510(k) K010270

TREMOROMETER by Flexable Systems, Inc. — Product Code GYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2001
Date Received
January 29, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Tremor
Device Class
Class II
Regulation Number
882.1950
Review Panel
NE
Submission Type