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FDA 510(k)

AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100

K-Number: K043550 · 2005-01-27

ApplicantAmplife Corporation
Decision Date2005-01-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 is the device name listed in this FDA 510(k) record. The listed applicant is Amplife Corporation. It received FDA 510(k) clearance on 2005-01-27 under 510(k) number K043550. 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 AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100?

AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 is a medical device that received FDA 510(k) clearance on 2005-01-27. The listed applicant is Amplife Corporation. The 510(k) number is K043550.

When did AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 receive FDA 510(k) clearance?

AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 received FDA 510(k) clearance on 2005-01-27, under 510(k) number K043550.

Who is the listed applicant for AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100?

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

What is the FDA product code for AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100?

The FDA product code for AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 is DXN.

Related Clinical Trials

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.

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Other records listing Amplife Corporation 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.

K050413AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600K042906AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101K042575AMPLIFE DIGITAL CLINICAL THERMOMETER

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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