Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C

K-Number: K010686 · 2001-03-21

ApplicantGolden Horse Medical Equipment (Wuxi) Co. , Ltd.
Decision Date2001-03-21
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C is the device name listed in this FDA 510(k) record. The listed applicant is Golden Horse Medical Equipment (Wuxi) Co. , Ltd.. It received FDA 510(k) clearance on 2001-03-21 under 510(k) number K010686. 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 KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C?

KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C is a medical device that received FDA 510(k) clearance on 2001-03-21. The listed applicant is Golden Horse Medical Equipment (Wuxi) Co. , Ltd.. The 510(k) number is K010686.

When did KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C receive FDA 510(k) clearance?

KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C received FDA 510(k) clearance on 2001-03-21, under 510(k) number K010686.

Who is the listed applicant for KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C?

The FDA 510(k) record lists Golden Horse Medical Equipment (Wuxi) Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C?

The FDA product code for KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C is DXQ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Golden Horse Medical Equipment (Wuxi) Co. , Ltd. as applicant

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.

K043444MULTIPLE, MODEL KTJ-50

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.

↑