Home / 510(k) Clearances / K210560

510(k) K210560

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2021
Date Received
February 25, 2021
Clearance Type
Special
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)
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  • K232161 — DeepRhythm Platform (June 20, 2024)