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FDA 510(k)

BRENEB

K-Number: K982043 · 1998-11-09

ApplicantBremed Italia, S.R.L.
Decision Date1998-11-09
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BRENEB is the device name listed in this FDA 510(k) record. The listed applicant is Bremed Italia, S.R.L.. It received FDA 510(k) clearance on 1998-11-09 under 510(k) number K982043. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRENEB?

BRENEB is a medical device that received FDA 510(k) clearance on 1998-11-09. The listed applicant is Bremed Italia, S.R.L.. The 510(k) number is K982043.

When did BRENEB receive FDA 510(k) clearance?

BRENEB received FDA 510(k) clearance on 1998-11-09, under 510(k) number K982043.

Who is the listed applicant for BRENEB?

The FDA 510(k) record lists Bremed Italia, S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRENEB?

The FDA product code for BRENEB is CAF.

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Other records listing Bremed Italia, S.R.L. 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.

K974379ULTRANEBK970542MASTER NEB II

Related Devices (Code: CAF)

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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