510(k) K971407

JTECH COMMANDER AND ALGOMETER by J-Tech Medical, Inc. — Product Code HRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1998
Date Received
April 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dynamometer, Nonpowered
Device Class
Class I
Regulation Number
888.1250
Review Panel
NE
Submission Type