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510(k) K890913

SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT by Shimadzu Precision Instruments, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1989
Date Received
February 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Shimadzu Precision Instruments, Inc.

  • K940294 — SHIMADZU MOBILE X-RAY SYSTEMS (March 16, 1994)
  • K884598 — SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 (April 20, 1989)
  • K884477 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B (March 15, 1989)
  • K875378 — SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION (November 16, 1988)
  • K882311 — SHIMADZU LATERAL C-ARM MH-31 (September 14, 1988)
  • K881674 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC (September 2, 1988)
  • K874910 — SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200 (July 1, 1988)
  • K881795 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K (July 1, 1988)
  • K875370 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX (May 18, 1988)
  • K874946 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 (March 3, 1988)

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