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FDA 510(k)

Digistat Care

K-Number: K261287 · 2026-09-12

ApplicantAscom Ums Srl Unipersonale
Decision Date2026-09-12
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digistat Care is the device name listed in this FDA 510(k) record. The listed applicant is Ascom Ums Srl Unipersonale. It received FDA 510(k) clearance on 2026-09-12 under 510(k) number K261287. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digistat Care?

Digistat Care is a medical device that received FDA 510(k) clearance on 2026-09-12. The listed applicant is Ascom Ums Srl Unipersonale. The 510(k) number is K261287.

When did Digistat Care receive FDA 510(k) clearance?

Digistat Care received FDA 510(k) clearance on 2026-09-12, under 510(k) number K261287.

Who is the listed applicant for Digistat Care?

The FDA 510(k) record lists Ascom Ums Srl Unipersonale as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digistat Care?

The FDA product code for Digistat Care is MSX.

Other records listing Ascom Ums Srl Unipersonale 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.

K180430Digistat Smart Central

Related Devices (Code: MSX)

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.

K260211Dashboard (P007000)Hill-Rom, Inc.K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbHK243270TigerConnect Alarm ManagementTigerconnectK242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.K242750Central StationNihon Kohden Digital Health Solutions, LLC

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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