Home / 510(k) Clearances / K954220

510(k) K954220

EUB-8000 by Hitachi Medical Corp. of America — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1997
Date Received
September 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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  • 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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