Home / 510(k) Clearances / K191738

510(k) K191738

PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph by Philips Medical Systems — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2020
Date Received
June 28, 2019
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

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  • K243305 — Masimo W1 (April 3, 2025)
  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
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  • K232161 — DeepRhythm Platform (June 20, 2024)