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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 the device name listed in this FDA 510(k) record. The listed applicant is I.E.M. GmbH. It received FDA 510(k) clearance on 2016-07-19 under 510(k) 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. The listed applicant is I.E.M. GmbH. The 510(k) number is K153557.

When did ABPM 7100, Hypertension Management Software receive FDA 510(k) clearance?

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

Who is the listed applicant for ABPM 7100, Hypertension Management Software?

The FDA 510(k) record lists I.E.M. GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: DXN)

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.

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Official Source

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

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