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FDA 510(k)

BM3/BM3 PLUS

K-Number: K132033 · 2013-12-04

ApplicantNoblitt & Rueland
Decision Date2013-12-04
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BM3/BM3 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Noblitt & Rueland. It received FDA 510(k) clearance on 2013-12-04 under 510(k) number K132033. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BM3/BM3 PLUS?

BM3/BM3 PLUS is a medical device that received FDA 510(k) clearance on 2013-12-04. The listed applicant is Noblitt & Rueland. The 510(k) number is K132033.

When did BM3/BM3 PLUS receive FDA 510(k) clearance?

BM3/BM3 PLUS received FDA 510(k) clearance on 2013-12-04, under 510(k) number K132033.

Who is the listed applicant for BM3/BM3 PLUS?

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

What is the FDA product code for BM3/BM3 PLUS?

The FDA product code for BM3/BM3 PLUS is MWI.

Related Devices (Code: MWI)

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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