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FDA 510(k)

Meditech ABPM-06 (BP6)

K-Number: K201332 · 2021-02-10

ApplicantMeditech , Ltd.
Decision Date2021-02-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Meditech ABPM-06 (BP6) is the device name listed in this FDA 510(k) record. The listed applicant is Meditech , Ltd.. It received FDA 510(k) clearance on 2021-02-10 under 510(k) number K201332. 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 ABPM-06 (BP6)?

Meditech ABPM-06 (BP6) is a medical device that received FDA 510(k) clearance on 2021-02-10. The listed applicant is Meditech , Ltd.. The 510(k) number is K201332.

When did Meditech ABPM-06 (BP6) receive FDA 510(k) clearance?

Meditech ABPM-06 (BP6) received FDA 510(k) clearance on 2021-02-10, under 510(k) number K201332.

Who is the listed applicant for Meditech ABPM-06 (BP6)?

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

What is the FDA product code for Meditech ABPM-06 (BP6)?

The FDA product code for Meditech ABPM-06 (BP6) is DXN.

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

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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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