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510(k) K962308

EUB-905 by Hitachi Medical Corp. of America — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1996
Date Received
June 17, 1996
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

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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)
  • K954143 — HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS (December 22, 1995)
  • K954129 — SPECTRADIGITAL SERIES V250DSP (December 22, 1995)
  • K945400 — HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 (November 20, 1995)
  • K945795 — EUB-555A+ (October 27, 1995)

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