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FDA 510(k)

FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS

K-Number: K062484 · 2007-06-08

ApplicantFlaem Nuova S.P.A.
Decision Date2007-06-08
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS 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 2007-06-08 under 510(k) number K062484. 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 FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS?

FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS is a medical device that received FDA 510(k) clearance on 2007-06-08. The listed applicant is Flaem Nuova S.P.A.. The 510(k) number is K062484.

When did FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS receive FDA 510(k) clearance?

FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS received FDA 510(k) clearance on 2007-06-08, under 510(k) number K062484.

Who is the listed applicant for FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS?

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 FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS?

The FDA product code for FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS 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.

K062014FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB

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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