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FDA 510(k)

Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff

K-Number: K153251 · 2016-04-14

ApplicantNingbo Free Trade Zone Tenso Medical Instruments Co., Ltd.
Decision Date2016-04-14
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff is a medical device manufactured by Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2016-04-14 under approval number K153251. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff?

Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff is a medical device that received FDA 510(k) clearance on 2016-04-14. It is manufactured by Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd.. The 510(k) number is K153251.

When was Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff approved by the FDA?

Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff received FDA 510(k) clearance on 2016-04-14, under approval number K153251.

What company makes Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff?

Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff is manufactured by Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd..

What is the FDA product code for Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff?

The FDA product code for Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff is DXQ.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

Related Devices (Code: DXQ)

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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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