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FDA 510(k)

FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT

K-Number: K093831 · 2010-03-25

ApplicantHealth & Life Co., Ltd.
Decision Date2010-03-25
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT is the device name listed in this FDA 510(k) record. The listed applicant is Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2010-03-25 under 510(k) number K093831. 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 FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT?

FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT is a medical device that received FDA 510(k) clearance on 2010-03-25. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K093831.

When did FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT receive FDA 510(k) clearance?

FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT received FDA 510(k) clearance on 2010-03-25, under 510(k) number K093831.

Who is the listed applicant for FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT?

The FDA 510(k) record lists Health & Life Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT?

The FDA product code for FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT is DXN.

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Other records listing Health & Life Co., Ltd. as applicant

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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