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510(k) K897042

EUB-515 DIAGNOSTIC ULTRASOUND DEVICE by Hitachi Medical Corp. of America — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1990
Date Received
December 18, 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 Hitachi Medical Corp. of America

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  • K991129 — HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL (May 13, 1999)
  • K981434 — EUP-OL334 LAPARASCOPICPROBE (July 27, 1998)
  • K954220 — EUB-8000 (May 7, 1997)
  • K962308 — EUB-905 (July 17, 1996)
  • K954129 — SPECTRADIGITAL SERIES V250DSP (December 22, 1995)
  • K954143 — HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS (December 22, 1995)
  • K945400 — HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 (November 20, 1995)

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