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)

MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO

K-Number: K851664 · 1985-07-24

ApplicantSharp Electronics Corp.
Decision Date1985-07-24
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO is the device name listed in this FDA 510(k) record. The listed applicant is Sharp Electronics Corp.. It received FDA 510(k) clearance on 1985-07-24 under 510(k) number K851664. 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 MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO?

MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO is a medical device that received FDA 510(k) clearance on 1985-07-24. The listed applicant is Sharp Electronics Corp.. The 510(k) number is K851664.

When did MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO receive FDA 510(k) clearance?

MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO received FDA 510(k) clearance on 1985-07-24, under 510(k) number K851664.

Who is the listed applicant for MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO?

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

What is the FDA product code for MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO?

The FDA product code for MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO 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 Sharp Electronics 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.

K880715(MB-650) BLOOD PRESSURE MONITORK875093NEW MODEL MB-550 BLOOD PRESSURE MONITORK863672MODEL (MB-700) BLOOD PRESSURE MONITORK861375MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORSK862333(MT-27) THERMOMETER AND (M-10PC) PROBE COVERSK852194MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET

View all 10 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.

↑