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510(k) Data Aggregation
K Number
K062484Device Name
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
Manufacturer
FLAEM NUOVA S.P.A.
Date Cleared
2007-06-08
(287 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
FLAEM NUOVA S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are reusable single patient use nebulizers which are used where a fine aerosol mist of medication must be delivered to a patient for the treatment of respiratory disorders. The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are intended to be used for both adult and pediatric patients who have been prescribed inhalation therapy or medication in both home health care and hospital use. The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers may be used with compressed air or an air gas source providing air flow between 4 to 10 lmin.
Device Description
The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are hand-held, reusable, single patient use and pneumatically powered nebulizers. Both devices are made using similar materials and are used by patients with the same accessories set (mouthpiece, masks etc ... ). The primary difference between the two devices is that the RF6 Plus is equipped with inspiration and expiration valves while the RF6 Basic is not.
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K Number
K062014Device Name
FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB
Manufacturer
FLAEM NUOVA S.P.A.
Date Cleared
2007-03-22
(248 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
FLAEM NUOVA S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The nebulizer compressors Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, and Q03 are intended to provide a source of compressed air for medical purposes, to be used in home health care and hospital use. The Walkie-Neb model is intended to be used only in home health care.
These devices are indicated for use with all commercially available small volume pneumatic nebulizers, to produce a fine aerosol mist of medication for respiratory therapy, for both adult and pediatric patients who have been prescribed inhalation therapy or medication.
Device Description
The nebulizer compressors Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb. FJ03, Q03 and Walkie-Neb are a family of nebulizer compressors intended to be used as compressed air generators for pneumatic nebulizers used by patients for aerosol therapy. There are 7 model families with an AC powered motor (Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, and Q03) and one model with a DC low voltage motor (Walkie-Neb), with a rechargeable battery pack and an external charger/power supplier.
The 7 AC model families have different plastic housings, which define the model name of the product. Inside they have the same compressor but with different electrical motors, to provide different pneumatic performances.
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