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510(k) K002258

ULTRAGUIDE CT-GUIDE 1010 by Ultraguide , Ltd. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2000
Date Received
July 25, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by Ultraguide , Ltd.

  • K023227 — USG 2000SA (October 22, 2002)
  • K022354 — ULTRAGUIDE CTG 2000SA (August 13, 2002)
  • K013150 — MR-GUIDE 2000 (October 18, 2001)
  • K011418 — ULTRAGUIDE MR-GUIDE 3000 (May 24, 2001)
  • K974432 — ULTRAGUIDE 1000 (February 9, 1998)

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