PageWriter TC35 Cardiograph
by Medizin Systeme Boblingen GmbH 510(k)
Active
510(k) K221141
Overview
The PageWriter TC35 Cardiograph is an electrocardiograph device designed to facilitate the production of ECG reports. It features a touchscreen display and an operation interface intended for use in hospital and clinic practice settings.
This device is classified as an electrocardiograph under product code DPS and has received FDA 510(k) clearance. It is manufactured by Medizin Systeme Boblingen GmbH and is identified by K-number K221141.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK221141 | Date2 Dec 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the primary function of the PageWriter TC35 Cardiograph?
The PageWriter TC35 is an electrocardiograph device specifically designed to facilitate the production of ECG reports. It is intended for use by clinicians within hospital and clinic practice settings to support cardiac diagnostic workflows.
What interface features does the PageWriter TC35 offer?
This device is equipped with a touchscreen display and a dedicated operation interface. These features are designed to streamline the user experience for healthcare professionals when generating electrocardiogram reports in a busy clinical environment.
What is the regulatory status of the PageWriter TC35 Cardiograph?
The PageWriter TC35 Cardiograph has received FDA 510(k) clearance under K-number K221141. It is classified as an electrocardiograph under product code DPS and was determined to be substantially equivalent to existing devices by the cardiovascular advisory committee.