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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 the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2016-04-14 under 510(k) 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. The listed applicant is Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd.. The 510(k) number is K153251.

When did Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff receive FDA 510(k) clearance?

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

Who is the listed applicant for Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff?

The FDA 510(k) record lists Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: DXQ)

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.

K254287Medline Reusable Blood Pressure CuffMedline Industries, LPK260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden CorporationK253089NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)Shenzhen Best Electronics Co., Ltd.K253964Disposable Neonatal NIBP Cuff (U1681S-C51N)Unimed Medical Supplies, Inc.K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)Baxter Healthcare CorporationK250765AViTA Arm Type Blood Pressure Monitor CuffAvita Corporation

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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