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510(k) K920183

TECH DYNE - HP-2000, SKREEN TEST, RMS-200 by Tech Dyne Group — Product Code LBB

K920183 is an FDA 510(k) premarket notification submitted by Tech Dyne Group for the device "TECH DYNE - HP-2000, SKREEN TEST, RMS-200". The FDA issued a decision of Substantially Equivalent on June 15, 1992. 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
June 15, 1992
Date Received
January 15, 1992
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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  • K981730 — DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 (July 17, 1998)
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  • K964933 — MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) (February 3, 1997)
  • K964685 — DYNAMOMETER (January 27, 1997)
  • K935757 — GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM (April 15, 1994)

FDA data resources