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 a medical device manufactured by Medizin Systeme Boblingen GmbH. It received FDA 510(k) clearance on 2022-12-02 under approval 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. It is manufactured by Medizin Systeme Boblingen GmbH. The 510(k) number is K221141.
When was PageWriter TC35 Cardiograph approved by the FDA?
PageWriter TC35 Cardiograph received FDA 510(k) clearance on 2022-12-02, under approval number K221141.
What company makes PageWriter TC35 Cardiograph?
PageWriter TC35 Cardiograph is manufactured by Medizin Systeme Boblingen GmbH.
What is the FDA product code for PageWriter TC35 Cardiograph?
The FDA product code for PageWriter TC35 Cardiograph is DPS.
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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.