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510(k) K903085

SMS-712NA by Toshiba America Medical Systems, In.C — Product Code GXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1990
Date Received
July 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echoencephalograph
Device Class
Class II
Regulation Number
882.1240
Review Panel
NE
Submission Type

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  • K121076 — ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE (October 9, 2012)
  • K122842 — RADREX-I, SW V4.00 MODEL DRAD-3000E (October 9, 2012)
  • K122109 — AQUILION ONE VISION, V4.90 (September 21, 2012)

Other clearances for product code GXW

  • K921863 — SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS (September 28, 1992)
  • K853432 — 5.0 IOP & 7.5 IOP PROBES (February 7, 1986)
  • K833522 — NEURO SECTOR FIXATION DEVICE (May 25, 1984)
  • K821736 — ECHO-PULSE KM555 (December 9, 1982)
  • K770788 — ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 (May 6, 1977)
  • K770575 — ECHOENCEPHALOGRAPH, DIGITAL, 1000 (April 26, 1977)