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FDA 510(k)

BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520

K-Number: K001543 · 2001-01-29

ApplicantWelch Allyn, Inc.
Decision Date2001-01-29
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2001-01-29 under 510(k) number K001543. 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 BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520?

BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 is a medical device that received FDA 510(k) clearance on 2001-01-29. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K001543.

When did BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 receive FDA 510(k) clearance?

BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 received FDA 510(k) clearance on 2001-01-29, under 510(k) number K001543.

Who is the listed applicant for BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520?

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

What is the FDA product code for BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520?

The FDA product code for BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 is DXN.

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Other records listing Welch Allyn, Inc. as applicant

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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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