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FDA 510(k)

ABPM 7100, Hypertension Management Software

K-Number: K153557 · 2016-07-19

ApplicantI.E.M. GmbH
Decision Date2016-07-19
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ABPM 7100, Hypertension Management Software is a medical device manufactured by I.E.M. GmbH. It received FDA 510(k) clearance on 2016-07-19 under approval number K153557. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABPM 7100, Hypertension Management Software?

ABPM 7100, Hypertension Management Software is a medical device that received FDA 510(k) clearance on 2016-07-19. It is manufactured by I.E.M. GmbH. The 510(k) number is K153557.

When was ABPM 7100, Hypertension Management Software approved by the FDA?

ABPM 7100, Hypertension Management Software received FDA 510(k) clearance on 2016-07-19, under approval number K153557.

What company makes ABPM 7100, Hypertension Management Software?

ABPM 7100, Hypertension Management Software is manufactured by I.E.M. GmbH.

What is the FDA product code for ABPM 7100, Hypertension Management Software?

The FDA product code for ABPM 7100, Hypertension Management Software is DXN.

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Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 40409423 Navigating regulatory challenges across the life cycle of a SaMD. Journal of biomedical informatics (2025)

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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.

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