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510(k) K830830

CIRCA MED TWO-CHANNEL by Circadian, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1983
Date Received
March 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Circadian, Inc.

  • K921878 — SCANMATE III (September 11, 1992)
  • K894956 — CIRCAMED HOLTER VERSION 4 (February 5, 1990)
  • K874641 — CIRCADIAN STRESS TEST II (April 1, 1988)
  • K874155 — CIRCAMED MONITOR REMOTE START CONDUCTANCE METER (November 23, 1987)
  • K871251 — CIRCAMED FULL DISCLOSURE SYSTEM (May 22, 1987)
  • K860973 — CIRCADIAN STRESS TEST SYSTEM (August 25, 1986)
  • K851517 — CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO (October 2, 1985)
  • K851643 — REMOTE CONTROL MODULE (September 9, 1985)
  • K840741 — PULMONARY FUNCTION TESTING STS (March 5, 1984)
  • K833619 — CONDUCTANCE METER (January 27, 1984)

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