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FDA 510(k)

PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM

K-Number: K053185 · 2006-01-24

ApplicantMedwave, Inc.
Decision Date2006-01-24
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medwave, Inc.. It received FDA 510(k) clearance on 2006-01-24 under 510(k) number K053185. 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 PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM?

PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-01-24. The listed applicant is Medwave, Inc.. The 510(k) number is K053185.

When did PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM receive FDA 510(k) clearance?

PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM received FDA 510(k) clearance on 2006-01-24, under 510(k) number K053185.

Who is the listed applicant for PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM?

The FDA 510(k) record lists Medwave, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM?

The FDA product code for PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM 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 Medwave, Inc. 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.

K061557FUSIONK011152VASOTRAC APM205AK001898VASOTRAXK950249VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205

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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