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FDA 510(k)

FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB

K-Number: K062014 · 2007-03-22

ApplicantFlaem Nuova S.P.A.
Decision Date2007-03-22
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB is the device name listed in this FDA 510(k) record. The listed applicant is Flaem Nuova S.P.A.. It received FDA 510(k) clearance on 2007-03-22 under 510(k) number K062014. 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 FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB?

FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB is a medical device that received FDA 510(k) clearance on 2007-03-22. The listed applicant is Flaem Nuova S.P.A.. The 510(k) number is K062014.

When did FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB receive FDA 510(k) clearance?

FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB received FDA 510(k) clearance on 2007-03-22, under 510(k) number K062014.

Who is the listed applicant for FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB?

The FDA 510(k) record lists Flaem Nuova S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB?

The FDA product code for FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB is CAF.

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Other records listing Flaem Nuova S.P.A. 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.

K062484FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS

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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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