PageWriter TC35 Cardiograph

FDA 510(k) K221141 · Medizin Systeme Boblingen GmbH

Substantially Equivalent

510(k) numberK221141

Submission

Device name
PageWriter TC35 Cardiograph
Applicant
Medizin Systeme Boblingen GmbH
Boblingen, DE
Received
April 19, 2022
Decision date
December 2, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPS – Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2340
Specialty
Cardiovascular

Other 510(k)s with product code DPS

510(k)DeviceApplicantDecision
K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional Edan Instruments, Inc.07/02/2026SE
K251670MAC 7 Resting ECG Analysis SystemDPS · Traditional Ge Medical Systems Information Technologies, Inc.01/26/2026SE
K252361AccurECG Analysis System (v2.0)DPS · Traditional Accurkardia, Inc.12/22/2025SE
K252474Withings BeamO (SCT02)DPS · Traditional Withings11/10/2025SE
K250569Cardiologs Holter PlatformDPS · Traditional Philips France Commercial08/06/2025SE
K243252ZBPro DiagnosticDPS · Traditional Zbeats, Inc.07/10/2025SE
K243305Masimo W1DPS · Traditional Masimo Corporation04/03/2025SE
K241217CloudHRV™ System (100-01-001)DPS · Traditional Inmedix, Inc.01/16/2025SE
K241556Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional Philips Medizin Systeme Böblingen GmbH12/17/2024SE
K240229Masimo W1DPS · Traditional Masimo Corporation08/08/2024SE

Questions and answers

When was PageWriter TC35 Cardiograph cleared by the FDA?

PageWriter TC35 Cardiograph (K221141) received a 510(k) decision of Substantially Equivalent on December 2, 2022, 227 days after the submission was received.

What is the product code of K221141?

The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.