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FDA 510(k)

QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200

K-Number: K083078 · 2008-11-26

ApplicantQuanta Computer, Inc.
Decision Date2008-11-26
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 is the device name listed in this FDA 510(k) record. The listed applicant is Quanta Computer, Inc.. It received FDA 510(k) clearance on 2008-11-26 under 510(k) number K083078. 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 QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200?

QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 is a medical device that received FDA 510(k) clearance on 2008-11-26. The listed applicant is Quanta Computer, Inc.. The 510(k) number is K083078.

When did QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 receive FDA 510(k) clearance?

QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 received FDA 510(k) clearance on 2008-11-26, under 510(k) number K083078.

Who is the listed applicant for QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200?

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

What is the FDA product code for QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200?

The FDA product code for QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 is DXN.

Related Clinical Trials

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Other records listing Quanta Computer, 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.

K231855QOCA® image Smart RT Contouring SystemK221868QOCA image Smart CXR Image Processing SystemK210179QOCA Portable ECG Monitoring DeviceK083079QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100

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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