FDA 510(k)

Tonomètre à manomètre avec stéthoscope; Tonomètre à manomètre

Numéro K : K240165 · 2024-03-20

DemandeurWenzhou Longwan Medical Device Factory

Date de décision2024-03-20

Code produitDXQ

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer is the device name listed in this FDA 510(k) record. The listed applicant is Wenzhou Longwan Medical Device Factory. It received FDA 510(k) clearance on 2024-03-20 under 510(k) number K240165. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer?

Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer is a medical device that received FDA 510(k) clearance on 2024-03-20. The listed applicant is Wenzhou Longwan Medical Device Factory. The 510(k) number is K240165.

When did Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer receive FDA 510(k) clearance?

Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer received FDA 510(k) clearance on 2024-03-20, under 510(k) number K240165.

Who is the listed applicant for Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer?

The FDA 510(k) record lists Wenzhou Longwan Medical Device Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer?

The FDA product code for Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer is DXQ.

Essais cliniques associés

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Dispositifs connexes (Code : DXQ)

K254287Medline Reusable Blood Pressure CuffMedline Industries, LP K260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden Corporation K253089NIBP 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 Corporation K250765AViTA Manchon de Tension Artérielle au BrasAvita Corporation

Source officielle

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