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FDA 510(k)

TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11

K-Number: K081852 · 2008-12-12

ApplicantTruly Instrument Limited
Decision Date2008-12-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 is the device name listed in this FDA 510(k) record. The listed applicant is Truly Instrument Limited. It received FDA 510(k) clearance on 2008-12-12 under 510(k) number K081852. 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 TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11?

TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 is a medical device that received FDA 510(k) clearance on 2008-12-12. The listed applicant is Truly Instrument Limited. The 510(k) number is K081852.

When did TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 receive FDA 510(k) clearance?

TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 received FDA 510(k) clearance on 2008-12-12, under 510(k) number K081852.

Who is the listed applicant for TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11?

The FDA 510(k) record lists Truly Instrument Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11?

The FDA product code for TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 is DXN.

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Other records listing Truly Instrument Limited 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.

K220276Infrared Thermometer TET-351K192023Arm Blood Pressure MonitorK161846Automatic Arm Bluetooth Blood Pressure MonitorK090564TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370

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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