# K221141: PageWriter TC35 Cardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Medizin Systeme Boblingen GmbH
- Decided: Dec 2, 2022 after 227 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K895520 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210560: Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph, Philips Medical Systems (2021) Summary page 4.

## Indications for use
The PageWriter TC35 Cardiograph is intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze and store these ECG signals for review by the user. It is to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user. The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over-read and validate (or change) the computer generated ECG interpretation.

Source page: https://510kreport.com/device/K221141
Methodology: https://510kreport.com/methodology