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FDA 510(k)

A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR

K-Number: K061456 · 2006-06-21

ApplicantA&D Engineering, Inc.
Decision Date2006-06-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is A&D Engineering, Inc.. It received FDA 510(k) clearance on 2006-06-21 under 510(k) number K061456. 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 A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR?

A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 2006-06-21. The listed applicant is A&D Engineering, Inc.. The 510(k) number is K061456.

When did A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR receive FDA 510(k) clearance?

A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 2006-06-21, under 510(k) number K061456.

Who is the listed applicant for A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR?

The FDA 510(k) record lists A&D Engineering, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR?

The FDA product code for A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR is DXN.

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Other records listing A&D Engineering, Inc. 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.

K082734A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITORK062027A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITORK043217A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITORK042967A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512K040371A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITORK040229A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328

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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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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