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FDA 510(k)

APM BLOOD PRESSURE MONITOR, MODEL BP108A

K-Number: K040159 · 2004-03-22

ApplicantAsia Pacific Microsystems, Inc.
Decision Date2004-03-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APM BLOOD PRESSURE MONITOR, MODEL BP108A is the device name listed in this FDA 510(k) record. The listed applicant is Asia Pacific Microsystems, Inc.. It received FDA 510(k) clearance on 2004-03-22 under 510(k) number K040159. 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 APM BLOOD PRESSURE MONITOR, MODEL BP108A?

APM BLOOD PRESSURE MONITOR, MODEL BP108A is a medical device that received FDA 510(k) clearance on 2004-03-22. The listed applicant is Asia Pacific Microsystems, Inc.. The 510(k) number is K040159.

When did APM BLOOD PRESSURE MONITOR, MODEL BP108A receive FDA 510(k) clearance?

APM BLOOD PRESSURE MONITOR, MODEL BP108A received FDA 510(k) clearance on 2004-03-22, under 510(k) number K040159.

Who is the listed applicant for APM BLOOD PRESSURE MONITOR, MODEL BP108A?

The FDA 510(k) record lists Asia Pacific Microsystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APM BLOOD PRESSURE MONITOR, MODEL BP108A?

The FDA product code for APM BLOOD PRESSURE MONITOR, MODEL BP108A is DXN.

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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

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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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