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510(k) K861233

DUAL PHOTON BONE DENSITOMETER by Medical and Scientific Enterprises, Inc. — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1987
Date Received
April 1, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer, Bone
Device Class
Class II
Regulation Number
892.1170
Review Panel
RA
Submission Type

Other clearances by Medical and Scientific Enterprises, Inc.

  • K933131 — BISTAT 70/70-I ELECTROSURGICAL UNIT (February 15, 1994)
  • K913881 — ENDOSTAT ELECTROSURGICAL UNIT (November 1, 1991)
  • K895855 — PHOENIX (January 22, 1990)
  • K882453 — POLYSCAN DIGITAL SCANNER (November 23, 1988)

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  • K180782 — Aria (April 20, 2018)
  • K161682 — GE Lunar DXA Bone Densitometers with enCORE version 17 (December 2, 2016)
  • K152299 — TBS iNsight (April 29, 2016)