FDA 510(k)

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)

K-Number: K113239 · 2012-03-16

Decision Date2012-03-16

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) 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 2012-03-16 under 510(k) number K113239. 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 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)?

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) is a medical device that received FDA 510(k) clearance on 2012-03-16. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K113239.

When did FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) receive FDA 510(k) clearance?

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) received FDA 510(k) clearance on 2012-03-16, under 510(k) number K113239.

Who is the listed applicant for FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)?

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 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)?

The FDA product code for FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) is DXN.

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Related Devices (Code: DXN)

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.