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510(k) K780307

CARDIAC MINIGRAPH by Arco Medical Products Co. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1978
Date Received
February 21, 1978
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 Arco Medical Products Co.

  • K802588 — MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. (November 19, 1980)
  • K801806 — EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE (September 9, 1980)
  • K801241 — UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. (June 30, 1980)
  • K800837 — PROGRAMMABLE BIPOLAR CARDIAC GENERATOR (June 30, 1980)
  • K800838 — ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. (June 4, 1980)
  • K800326 — ARCOLITH 3021-CARDIAC PULSE GENERATOR (March 17, 1980)
  • K792299 — ARCOLITH 3020-CARDIAC PULSE GENERATOR (November 29, 1979)
  • K792216 — ARCOLITH 2100-CARDIAC PULSE GENERATOR (November 29, 1979)
  • K791715 — ARCOLITH 2000 (September 27, 1979)
  • K791147 — ARCO PROGAMMABLE PACEMAKER SYSTEM (August 3, 1979)

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  • 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)