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510(k) K913079

02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 by Lucas Sensing Systems, Inc. — Product Code KQX

K913079 is an FDA 510(k) premarket notification submitted by Lucas Sensing Systems, Inc. for the device "02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360". The FDA issued a decision of Substantially Equivalent on September 25, 1991. The device falls under product code KQX (Goniometer, Ac-Powered), a Class I device regulated under 21 CFR 888.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1991
Date Received
July 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Goniometer, Ac-Powered
Device Class
Class I
Regulation Number
888.1500
Review Panel
NE
Submission Type

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  • K943898 — SAUNDERS ELECTRONIC INCLINOMETER (November 28, 1994)
  • K940812 — INSIGHT ELECTRONIC ALIGNMENT INDICATOR (November 21, 1994)
  • K925225 — THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK (June 27, 1994)

FDA data resources