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510(k) K782036

TREMOR MONITOR by Columbus Instruments Intl. Corp. — Product Code GYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1979
Date Received
December 5, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Tremor
Device Class
Class II
Regulation Number
882.1950
Review Panel
NE
Submission Type

Other clearances by Columbus Instruments Intl. Corp.

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  • K861543 — CARDIOMAX-II (March 10, 1987)
  • K861100 — ISO-THERMEX (May 12, 1986)
  • K771718 — CARDIOTHERM-500X (September 28, 1977)

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