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510(k) K012492

KADANCE 2000 by Kada Research, Inc. — Product Code LBB

K012492 is an FDA 510(k) premarket notification submitted by Kada Research, Inc. for the device "KADANCE 2000". The FDA issued a decision of Substantially Equivalent on November 2, 2001. The device falls under product code LBB (Dynamometer, Ac-Powered), a Class II device regulated under 21 CFR 888.1240.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2001
Date Received
August 3, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dynamometer, Ac-Powered
Device Class
Class II
Regulation Number
888.1240
Review Panel
NE
Submission Type

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  • K935757 — GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM (April 15, 1994)
  • K931321 — CSD 200/300/400/500 DYNAMOMETER (February 15, 1994)

FDA data resources