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510(k) K851133

TERRAN BIOMECHANICAL ANALYSIS SYSTEM by Terran Biomedical Instruments — Product Code LDK

K851133 is an FDA 510(k) premarket notification submitted by Terran Biomedical Instruments for the device "TERRAN BIOMECHANICAL ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on June 19, 1985. The device falls under product code LDK (Device, Sensing, Optical Contour), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1985
Date Received
March 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sensing, Optical Contour
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

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  • K860225 — METRICOM (February 11, 1986)
  • K844736 — ISIS (March 21, 1985)
  • K800591 — CONTOUROGRAPH M-500 (April 2, 1980)

FDA data resources