FDA 510(k)

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF

K-Number: K092161 · 2009-09-30

Decision Date2009-09-30

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF 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 2009-09-30 under 510(k) number K092161. 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 HL868BF?

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF is a medical device that received FDA 510(k) clearance on 2009-09-30. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K092161.

When did FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF receive FDA 510(k) clearance?

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF received FDA 510(k) clearance on 2009-09-30, under 510(k) number K092161.

Who is the listed applicant for FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF?

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 HL868BF?

The FDA product code for FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF 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.