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)

KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

K-Number: K080326 · 2008-07-31

ApplicantAndon Health Co, Ltd.
Decision Date2008-07-31
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2008-07-31 under 510(k) number K080326. 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 KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR?

KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 2008-07-31. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K080326.

When did KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR receive FDA 510(k) clearance?

KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 2008-07-31, under 510(k) number K080326.

Who is the listed applicant for KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR?

The FDA 510(k) record lists Andon Health Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR?

The FDA product code for KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR 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 Andon Health 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.

K251113iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood PrK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripK234041Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)K222869Arm Blood Pressure MonitorK222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)K212598iHealth infrared Ear thermometer PT5

View all 83 devices →

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.

↑