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FDA 510(k)

MONITOR, NON-INVASIVE BLOOD PRESSURE

K-Number: K782000 · 1978-12-05

ApplicantAutomated Screening Devices
Decision Date1978-12-05
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONITOR, NON-INVASIVE BLOOD PRESSURE is the device name listed in this FDA 510(k) record. The listed applicant is Automated Screening Devices. It received FDA 510(k) clearance on 1978-12-05 under 510(k) number K782000. 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 MONITOR, NON-INVASIVE BLOOD PRESSURE?

MONITOR, NON-INVASIVE BLOOD PRESSURE is a medical device that received FDA 510(k) clearance on 1978-12-05. The listed applicant is Automated Screening Devices. The 510(k) number is K782000.

When did MONITOR, NON-INVASIVE BLOOD PRESSURE receive FDA 510(k) clearance?

MONITOR, NON-INVASIVE BLOOD PRESSURE received FDA 510(k) clearance on 1978-12-05, under 510(k) number K782000.

Who is the listed applicant for MONITOR, NON-INVASIVE BLOOD PRESSURE?

The FDA 510(k) record lists Automated Screening Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONITOR, NON-INVASIVE BLOOD PRESSURE?

The FDA product code for MONITOR, NON-INVASIVE BLOOD PRESSURE 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.

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Other records listing Automated Screening Devices 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.

K792653SENTRY

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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