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510(k) K130409

ALIVECOR HEART MONITOR by AliveCor, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2013
Date Received
February 19, 2013
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

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Other clearances for product code DPS

  • K251670 — MAC 7 Resting ECG Analysis System (January 26, 2026)
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  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
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  • 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)