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FDA 510(k)

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package

K-Number: K182543 · 2018-11-14

ApplicantSnap40, Ltd.
Decision Date2018-11-14
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package is the device name listed in this FDA 510(k) record. The listed applicant is Snap40, Ltd.. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K182543. 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 ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package?

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Snap40, Ltd.. The 510(k) number is K182543.

When did Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package receive FDA 510(k) clearance?

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package received FDA 510(k) clearance on 2018-11-14, under 510(k) number K182543.

Who is the listed applicant for Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package?

The FDA 510(k) record lists Snap40, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package?

The FDA product code for Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package is MSX.

Related Clinical Trials

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.

NCT05053555High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver MalignanciesRECRUITINGNCT07441382Catheter Ablation Plus LAAO Versus Anticoagulation in Frail Elderly Patients With Atrial FibrillationRECRUITINGNCT07679243A Clinical Study on the Safety and Efficacy of Wide-Band Ultrasound Combined With Traditional Chinese Medicine Preparations in the Prevention and Treatment of KeloidsNOT_YET_RECRUITING

Related PubMed Literature

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.

PMID: 30115367The multiple arrhythmia dataset evaluation database (M.A.D.A.E.).Journal of electrocardiology (2018)

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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