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FDA 510(k)

TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM

K-Number: K061452 · 2006-07-12

ApplicantTung FU Electric Co., Ltd.
Decision Date2006-07-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tung FU Electric Co., Ltd.. It received FDA 510(k) clearance on 2006-07-12 under 510(k) number K061452. 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 TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM?

TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-12. The listed applicant is Tung FU Electric Co., Ltd.. The 510(k) number is K061452.

When did TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM receive FDA 510(k) clearance?

TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM received FDA 510(k) clearance on 2006-07-12, under 510(k) number K061452.

Who is the listed applicant for TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM?

The FDA 510(k) record lists Tung FU Electric Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM?

The FDA product code for TF-BP01 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 Tung FU Electric Co., Ltd. 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.

K042107TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001

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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