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510(k) K981434

EUP-OL334 LAPARASCOPICPROBE by Hitachi Medical Corp. of America — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1998
Date Received
April 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Hitachi Medical Corp. of America

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  • K991318 — CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS (June 18, 1999)
  • K991129 — HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL (May 13, 1999)
  • 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)
  • K945795 — EUB-555A+ (October 27, 1995)

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