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)

KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A

K-Number: K062893 · 2007-02-05

ApplicantShanghai Kodea Economic and Trade Development , Ltd.
Decision Date2007-02-05
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Kodea Economic and Trade Development , Ltd.. It received FDA 510(k) clearance on 2007-02-05 under 510(k) number K062893. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A?

KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A is a medical device that received FDA 510(k) clearance on 2007-02-05. The listed applicant is Shanghai Kodea Economic and Trade Development , Ltd.. The 510(k) number is K062893.

When did KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A receive FDA 510(k) clearance?

KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A received FDA 510(k) clearance on 2007-02-05, under 510(k) number K062893.

Who is the listed applicant for KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A?

The FDA 510(k) record lists Shanghai Kodea Economic and Trade Development , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A?

The FDA product code for KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A is DXN.

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

Related Devices (Code: DXN)

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.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

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.

↑