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FDA 510(k)

(MB-650) BLOOD PRESSURE MONITOR

K-Number: K880715 · 1988-05-09

ApplicantSharp Electronics Corp.
Decision Date1988-05-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

(MB-650) BLOOD PRESSURE MONITOR 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 1988-05-09 under 510(k) number K880715. 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 (MB-650) BLOOD PRESSURE MONITOR?

(MB-650) BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1988-05-09. The listed applicant is Sharp Electronics Corp.. The 510(k) number is K880715.

When did (MB-650) BLOOD PRESSURE MONITOR receive FDA 510(k) clearance?

(MB-650) BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 1988-05-09, under 510(k) number K880715.

Who is the listed applicant for (MB-650) BLOOD PRESSURE MONITOR?

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 (MB-650) BLOOD PRESSURE MONITOR?

The FDA product code for (MB-650) BLOOD PRESSURE MONITOR is DXN.

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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.

K875093NEW 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 THERMOMETK851664MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO

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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.

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