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FDA 510(k)

HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)

K-Number: K110603 · 2011-12-16

ApplicantI.E.M. GmbH
Decision Date2011-12-16
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) 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 2011-12-16 under 510(k) number K110603. 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 HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)?

HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is I.E.M. GmbH. The 510(k) number is K110603.

When did HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) receive FDA 510(k) clearance?

HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) received FDA 510(k) clearance on 2011-12-16, under 510(k) number K110603.

Who is the listed applicant for HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)?

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 HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)?

The FDA product code for HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) is DXN.

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Other records listing I.E.M. GmbH as applicant

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.

K153557ABPM 7100, Hypertension Management SoftwareK072446MOBIL-O-GRAPH NG 24 H ABP-CONTROLK041313STABIL-O-GRAPH

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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