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510(k) K860973

CIRCADIAN STRESS TEST SYSTEM by Circadian, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1986
Date Received
March 14, 1986
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)
  • 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)
  • K830830 — CIRCA MED TWO-CHANNEL (June 18, 1983)

Other clearances for product code DPS

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  • K252361 — AccurECG Analysis System (v2.0) (December 22, 2025)
  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
  • K250569 — Cardiologs Holter Platform (August 6, 2025)
  • K243252 — ZBPro Diagnostic (July 10, 2025)
  • K243305 — Masimo W1 (April 3, 2025)
  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K240229 — Masimo W1 (August 8, 2024)
  • K232161 — DeepRhythm Platform (June 20, 2024)