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FDA 510(k)

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

K-Number: K190073 · 2019-03-27

ApplicantCurrent Health , Ltd.
Decision Date2019-03-27
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub is the device name listed in this FDA 510(k) record. The listed applicant is Current Health , Ltd.. It received FDA 510(k) clearance on 2019-03-27 under 510(k) number K190073. 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 Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub is a medical device that received FDA 510(k) clearance on 2019-03-27. The listed applicant is Current Health , Ltd.. The 510(k) number is K190073.

When did Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub receive FDA 510(k) clearance?

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub received FDA 510(k) clearance on 2019-03-27, under 510(k) number K190073.

Who is the listed applicant for Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

The FDA 510(k) record lists Current Health , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

The FDA product code for Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub is MSX.

Other records listing Current Health , Ltd. 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.

K231506Current Health SystemK222550Current Health SystemK210133Current Health Monitoring System Gen 2 (G2)K191272Wearable Device, Wearable Package

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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