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510(k) K861543

CARDIOMAX-II by Columbus Instruments Intl. Corp. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1987
Date Received
April 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Columbus Instruments Intl. Corp.

  • K895791 — OXYMAX (March 28, 1990)
  • K861100 — ISO-THERMEX (May 12, 1986)
  • K782036 — TREMOR MONITOR (January 23, 1979)
  • K771718 — CARDIOTHERM-500X (September 28, 1977)

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