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FDA 510(k)

ULTRANEB

K-Number: K974379 · 1998-02-18

ApplicantBremed Italia, S.R.L.
Decision Date1998-02-18
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ULTRANEB 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 1998-02-18 under 510(k) number K974379. 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 ULTRANEB?

ULTRANEB is a medical device that received FDA 510(k) clearance on 1998-02-18. The listed applicant is Bremed Italia, S.R.L.. The 510(k) number is K974379.

When did ULTRANEB receive FDA 510(k) clearance?

ULTRANEB received FDA 510(k) clearance on 1998-02-18, under 510(k) number K974379.

Who is the listed applicant for ULTRANEB?

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 ULTRANEB?

The FDA product code for ULTRANEB 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.

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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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