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FDA 510(k)

MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05

K-Number: K071960 · 2007-08-03

ApplicantMeditech Kft.
Decision Date2007-08-03
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 is the device name listed in this FDA 510(k) record. The listed applicant is Meditech Kft.. It received FDA 510(k) clearance on 2007-08-03 under 510(k) number K071960. 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 MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05?

MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 is a medical device that received FDA 510(k) clearance on 2007-08-03. The listed applicant is Meditech Kft.. The 510(k) number is K071960.

When did MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 receive FDA 510(k) clearance?

MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 received FDA 510(k) clearance on 2007-08-03, under 510(k) number K071960.

Who is the listed applicant for MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05?

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

What is the FDA product code for MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05?

The FDA product code for MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 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 Meditech Kft. 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.

K051149MEDITECH MODEL ABPM-04

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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