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FDA 510(k)

Current Health Monitoring System Gen 2 (G2)

K-Number: K210133 · 2021-09-03

ApplicantCurrent Health
Decision Date2021-09-03
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Current Health Monitoring System Gen 2 (G2) is the device name listed in this FDA 510(k) record. The listed applicant is Current Health. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K210133. 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 Current Health Monitoring System Gen 2 (G2)?

Current Health Monitoring System Gen 2 (G2) is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Current Health. The 510(k) number is K210133.

When did Current Health Monitoring System Gen 2 (G2) receive FDA 510(k) clearance?

Current Health Monitoring System Gen 2 (G2) received FDA 510(k) clearance on 2021-09-03, under 510(k) number K210133.

Who is the listed applicant for Current Health Monitoring System Gen 2 (G2)?

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

What is the FDA product code for Current Health Monitoring System Gen 2 (G2)?

The FDA product code for Current Health Monitoring System Gen 2 (G2) is MSX.

Other records listing Current Health 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 SystemK191272Wearable Device, Wearable PackageK190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

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

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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