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510(k) K851643

REMOTE CONTROL MODULE by Circadian, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1985
Date Received
April 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
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)
  • K840741 — PULMONARY FUNCTION TESTING STS (March 5, 1984)
  • K833619 — CONDUCTANCE METER (January 27, 1984)
  • K830830 — CIRCA MED TWO-CHANNEL (June 18, 1983)

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  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
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  • K232161 — DeepRhythm Platform (June 20, 2024)