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FDA 510(k)

Wrist Blood Pressure Monitor Model BP6100

K-Number: K182127 · 2018-11-02

Decision Date2018-11-02
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist Blood Pressure Monitor Model BP6100 is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K182127. 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 Wrist Blood Pressure Monitor Model BP6100?

Wrist Blood Pressure Monitor Model BP6100 is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K182127.

When did Wrist Blood Pressure Monitor Model BP6100 receive FDA 510(k) clearance?

Wrist Blood Pressure Monitor Model BP6100 received FDA 510(k) clearance on 2018-11-02, under 510(k) number K182127.

Who is the listed applicant for Wrist Blood Pressure Monitor Model BP6100?

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

What is the FDA product code for Wrist Blood Pressure Monitor Model BP6100?

The FDA product code for Wrist Blood Pressure Monitor Model BP6100 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.

Other records listing Omron Healthcare, 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.

View all 14 devices →

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.

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.