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FDA 510(k)

COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM

K-Number: K053304 · 2005-12-30

ApplicantCardiocom, LLC
Decision Date2005-12-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocom, LLC. It received FDA 510(k) clearance on 2005-12-30 under 510(k) number K053304. 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 COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM?

COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-30. The listed applicant is Cardiocom, LLC. The 510(k) number is K053304.

When did COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM receive FDA 510(k) clearance?

COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM received FDA 510(k) clearance on 2005-12-30, under 510(k) number K053304.

Who is the listed applicant for COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM?

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

What is the FDA product code for COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM?

The FDA product code for COMMANDER III NON-INVASIVE BLOOD PRESSURE 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 Cardiocom, LLC 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.

K122285TABLET COMMANDERK091821COMMANDER 111, MODEL CD300-CD399K053303CARDIOCOM COMMANDER III

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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