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FDA 510(k)

TANGO NON-INVASIVE BLOOD PRESSURE MONITOR

K-Number: K970629 · 1998-01-02

ApplicantSuntech Medical Instruments, Inc.
Decision Date1998-01-02
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TANGO NON-INVASIVE BLOOD PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Suntech Medical Instruments, Inc.. It received FDA 510(k) clearance on 1998-01-02 under 510(k) number K970629. 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 TANGO NON-INVASIVE BLOOD PRESSURE MONITOR?

TANGO NON-INVASIVE BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1998-01-02. The listed applicant is Suntech Medical Instruments, Inc.. The 510(k) number is K970629.

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

TANGO NON-INVASIVE BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 1998-01-02, under 510(k) number K970629.

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

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

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

The FDA product code for TANGO NON-INVASIVE BLOOD PRESSURE MONITOR is DXN.

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Other records listing Suntech Medical Instruments, 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.

K010622PRESSURE TRAK, MODEL 222-BK003004OSCAR 2, MODEL 222K9142604240 DYNAMIC BP/HEART RATE MONITORK913844ACCUTRACKER DX

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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