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510(k) K014262

COSMED QUARK C12/QUARK T12 by Cosmed Srl — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2002
Date Received
December 27, 2001
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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  • K020745 — COSMED MICROQUARK (January 2, 2003)
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Other clearances for product code DPS

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  • K252361 — AccurECG Analysis System (v2.0) (December 22, 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)