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510(k) K940812

INSIGHT ELECTRONIC ALIGNMENT INDICATOR by Andronic Devices, Ltd. — Product Code KQX

K940812 is an FDA 510(k) premarket notification submitted by Andronic Devices, Ltd. for the device "INSIGHT ELECTRONIC ALIGNMENT INDICATOR". The FDA issued a decision of Substantially Equivalent on November 21, 1994. The device falls under product code KQX (Goniometer, Ac-Powered), a Class I device regulated under 21 CFR 888.1500. Andronic Devices, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1994
Date Received
February 22, 1994
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

Other clearances by Andronic Devices, Ltd.

  • K934928 — INSITE FILTER & TUBING SET (May 26, 1994)
  • K934926 — INSITE MODEL 20 & MODEL 15 INSUFFLATORS (May 26, 1994)
  • K935381 — KAPS POSITIONING ARM (April 15, 1994)
  • K934124 — AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM (April 13, 1994)
  • K936308 — ENDEX ENDOSCOPIC POSITIONING SYSTEM (March 31, 1994)
  • K932253 — ARTHROBOT BI-FOLD DRAPE (February 3, 1994)
  • K922625 — ADEPT ENDOSCOPIC POSITIONER (October 19, 1992)
  • K922626 — ADEPT INSTRUMENT POSITIONING ACCESSORY (October 19, 1992)
  • K911520 — ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE (August 2, 1991)
  • K911521 — ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP (August 2, 1991)

Other clearances for product code KQX

  • K011827 — ORTELIUS 800 (August 28, 2001)
  • K971079 — INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE (July 9, 1997)
  • K962377 — 3D-SPINE (September 3, 1996)
  • K961212 — SPINAL TOUCH (June 12, 1996)
  • K954647 — INCLINOMETER (October 30, 1995)
  • K943929 — DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) (May 15, 1995)
  • K945630 — LARGE MUSCLE STRENGTH GAUGE (May 10, 1995)
  • K943898 — SAUNDERS ELECTRONIC INCLINOMETER (November 28, 1994)
  • K925225 — THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK (June 27, 1994)
  • K933063 — ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA (January 27, 1994)

FDA data resources