FDA 510(k)

Hinscope

K-Number: K241397 · 2024-11-14

Decision Date2024-11-14

Product CodeMSX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Hinscope is the device name listed in this FDA 510(k) record. The listed applicant is Hinlab Sas. It received FDA 510(k) clearance on 2024-11-14 under 510(k) number K241397. 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 Hinscope?

Hinscope is a medical device that received FDA 510(k) clearance on 2024-11-14. The listed applicant is Hinlab Sas. The 510(k) number is K241397.

When did Hinscope receive FDA 510(k) clearance?

Hinscope received FDA 510(k) clearance on 2024-11-14, under 510(k) number K241397.

Who is the listed applicant for Hinscope?

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

What is the FDA product code for Hinscope?

The FDA product code for Hinscope is MSX.

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 GmbH K243270TigerConnect Alarm ManagementTigerconnect K242728BeneVision 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.