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FDA 510(k)

EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M

K-Number: K021239 · 2002-11-08

ApplicantEikon Healthcare Device Corp.
Decision Date2002-11-08
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M is the device name listed in this FDA 510(k) record. The listed applicant is Eikon Healthcare Device Corp.. It received FDA 510(k) clearance on 2002-11-08 under 510(k) number K021239. 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 EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M?

EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M is a medical device that received FDA 510(k) clearance on 2002-11-08. The listed applicant is Eikon Healthcare Device Corp.. The 510(k) number is K021239.

When did EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M receive FDA 510(k) clearance?

EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M received FDA 510(k) clearance on 2002-11-08, under 510(k) number K021239.

Who is the listed applicant for EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M?

The FDA 510(k) record lists Eikon Healthcare Device Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M?

The FDA product code for EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M 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

Other records listing Eikon Healthcare Device Corp. 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.

K021240EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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