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510(k) K950981

ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 by Biodex Medical Systems, Inc. — Product Code IXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1995
Date Received
March 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Tilting
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

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Other clearances for product code IXR

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  • K965105 — ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 (January 30, 1997)
  • K965096 — FLUOROVIEW SERIES FLUOROSCOPIC TABLES (January 27, 1997)
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  • K961022 — TANGENT VI TABLE (May 3, 1996)
  • K954356 — COMPAX 90/15E (October 7, 1995)
  • K953556 — VACS TABLE, 9650 (September 26, 1995)