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510(k) K771718

CARDIOTHERM-500X by Columbus Instruments Intl. Corp. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1977
Date Received
September 12, 1977
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)
  • K861543 — CARDIOMAX-II (March 10, 1987)
  • K861100 — ISO-THERMEX (May 12, 1986)
  • K782036 — TREMOR MONITOR (January 23, 1979)

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