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510(k) K926082

CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT by Biodan Medical Systems, Ltd. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1992
Date Received
December 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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  • K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520 (July 23, 1992)
  • K922772 — TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR (July 13, 1992)

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