Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PageWriter TC35 Cardiograph

K-Number: K221141 · 2022-12-02

ApplicantMedizin Systeme Boblingen GmbH
Decision Date2022-12-02
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PageWriter TC35 Cardiograph is the device name listed in this FDA 510(k) record. The listed applicant is Medizin Systeme Boblingen GmbH. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K221141. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PageWriter TC35 Cardiograph?

PageWriter TC35 Cardiograph is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Medizin Systeme Boblingen GmbH. The 510(k) number is K221141.

When did PageWriter TC35 Cardiograph receive FDA 510(k) clearance?

PageWriter TC35 Cardiograph received FDA 510(k) clearance on 2022-12-02, under 510(k) number K221141.

Who is the listed applicant for PageWriter TC35 Cardiograph?

The FDA 510(k) record lists Medizin Systeme Boblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PageWriter TC35 Cardiograph?

The FDA product code for PageWriter TC35 Cardiograph is DPS.

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑