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    K Number
    K242102
    Device Name
    CerroZone Mini
    Manufacturer
    CerroZone LLC
    Date Cleared
    2024-11-19

    (124 days)

    Product Code
    FRF
    Regulation Number
    880.5045
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CerroZone Mini is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles (i.e., bacteria and viruses) from the air for medical purposes.
    Device Description
    The CerroZone Mini is a medical recirculating air cleaner that uses multiple inactivation processes, including use of reactive oxidizing species (ozone) and ultraviolet radiation, to inactivate bacteria and viruses in the CerroZone Mini may be used in medical facilities. Once turned on, inlet air is passed through CerroZone Mini's inline flow-through design which inactivates bacteria and viruses in a single pass flow-through. The device generates 110 cubic feet of air per minute (CFM), or 2.00 air changes per hour (ACH) in a standard 5,600 cubic foot room. The process of air being inlet, purified, then outlet, lasts approximately 1.2 seconds. A 4 LOG reduction, or 99.99% reduction, of airborne particles in a standard 579 cubic foot room is achieved in 45 minutes or less.
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    K Number
    K240696
    Device Name
    Airdog X8 Air Purifier (KJ800F-X8)
    Manufacturer
    Suzhou Beiang Smart Technology Co., Ltd.
    Date Cleared
    2024-06-14

    (92 days)

    Product Code
    FRF
    Regulation Number
    880.5045
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Airdog X8 Air Purifier is a mobile air cleaner intended to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog X8 has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L5 speed.
    Device Description
    The Airdog X8 Air Purifier (X8) is a mobile air cleaner. The air from the room enters the X8 and passes a pre-filter, ionization frame, ionization field, collecting plates and carbon filter that captures particular matter and biological agents from the air. The X8 contains multiple PCB modules, device status indicators, power switch and a display panel, it allows user to select between different operation parameters, including auto-mode, sleep mode and wind speed. The Ionization wireframe and the collecting plate can be cleaned routinely and are reusable. X8 is powered from an AC wall outlet. It is intended to be used indoors only. The device is not intended to be connected to other instruments or medical devices.
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    K Number
    K223835
    Device Name
    MA-40, MA-112
    Manufacturer
    Medify Air LLC
    Date Cleared
    2023-09-18

    (270 days)

    Product Code
    FRF
    Regulation Number
    880.5045
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MA-40 and MA-112 are intended for use as room recirculating air cleaner. The systems are used for filtering out and inactivating airborne particles from the air for medical purposes. The MA-40 has been demonstrated to reduce the following airborne microorganisms by >99.99% in a test chamber of 83ft3 (580 ft3) BIOAEROSOL TYPE | SPECIES | DEVICE FAN SPEED | TOTAL TRIAL TIME (MINUTES) -----------------|-----------------------------|------------------|------------------------------- Virus | MS2 bacteriophage | Speed 3 | 30 | | Speed 2 | 45 | | Speed 1 | 90 Virus | Phi-X 174 bacteriophage | Speed 3 | 30 Bacterial | Staphylococcus Epidermidis | Speed 3 | 30 Bacterial | Escherichia coli | Speed 3 | 30 Bacterial | Bacillus Subtilis Endospore | Speed 3 | 30 | | Speed 2 | 45 | | Speed 1 | 120 Mold | Aspergillus Brasiliensis | Speed 3 | 30 The MA-112 has been demonstrated to reduce the following airborne microorganisms by >99.99% in a test chamber of 83ft3 (580 ft3) BIOAEROSOL TYPE | SPECIES | DEVICE FAN SPEED | TOTAL TRIAL TIME (MINUTES) -----------------|-----------------------------|------------------|------------------------------- Virus | MS2 bacteriophage | Speed 4 | 20 | | Speed 3 | | | Speed 2 | | | Speed 1 | Virus | Phi-X 174 bacteriophage | Speed 4 | 20 Bacterial | Staphylococcus Epidermidis | Speed 4 | 20 Bacterial | Escherichia coli | Speed 4 | 20 Bacterial | Bacillus Subtilis Endospore | Speed 4 | 20 | | Speed 3 | | | Speed 2 | | | Speed 1 | Mold | Aspergillus Brasiliensis | Speed 4 | 20
    Device Description
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    K Number
    K222416
    Device Name
    RIA Safeguard
    Manufacturer
    RIA Tech Co., Ltd.
    Date Cleared
    2023-05-01

    (264 days)

    Product Code
    FRF
    Regulation Number
    880.5045
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RIA SafeGuard is intended as a room recirculating air cleaner. The system is used for filtering out airborne particles PM2.5 from the air for medical purposes, and is intended for over-the-counter use. The RIA SafeGuard has wind speed of 1.3 m/s and airflow of 135 CMH (m3/h). Using the HEPA H13 filter, it provides a 4 log (99.99%) reduction in suspended particulate PM2.5 in 120 minutes within a 29.75 m³ room.
    Device Description
    RIA SafeGuard (SG020MS120) is an air purifier that contains the highefficiency HEPA technology and Bi-Polar Ionization (BPI) unit to remove 99.99% of particles as small as 2.5 microns from the air stream. SafeGuard addresses suspended particles with a single wind speed of 1.3 m/s, providing a 4 log reduction in PM2.5 particulates within 120 minutes in a 29.75 m³ space. The airflow is 135 CMH (m3/h). It is intended to be placed in a room such as medical care institutions and hospitals etc. RIA SafeGuard is a product that is designed as one-touch, easy to use, and no contact with patients. RIA SafeGuard has built in a blue LED as the switch-on indicator. All the maintenance should be done by a trained technician. Changing the HEPA is the only recommended maintenance to do by a non-trained technician, recommended renewing every 12 months.
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    K Number
    K211507
    Device Name
    Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
    Manufacturer
    Beiang Air Tech LTD.
    Date Cleared
    2022-11-22

    (557 days)

    Product Code
    FRF
    Regulation Number
    880.5045
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Airdog is a mobile air cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L4 speed.
    Device Description
    The Airdog X5 Recirculating Air Cleaner is a floor-standing air cleaner with an air quality sensor. The air from the room enters the X5 and passes a pre-filter, ionization frame, ionization field, collecting plates and carbon layer that captures particular matter and virus from the air. The X5 contains multiple PCB modules, air quality sensor, device status indicators, power switch and a display panel it allows user to select between different operation parameter, including auto-mode, sleep mode and wind speed. The Ionization Wireframe and the Collecting Plate can be cleaned routinely and are reusable. X5 is powered from an AC wall outlet. It is intended to be used indoors only.
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    K Number
    K220990
    Device Name
    Qorda QD1
    Manufacturer
    Winix Inc.
    Date Cleared
    2022-09-14

    (163 days)

    Product Code
    FRF
    Regulation Number
    880.5045
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Qorda QD is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes. The Qorda QD1 has been demonstrated to remove the following organisms under the following exposure conditions: | Organism | Fan Speed | Average Maximum log<br>reduction | Exposure Time | |----------------------------------------|------------|----------------------------------|---------------| | MS2 bacteriophage | Turbo MODE | 5.6 log reduction | 20 minutes | | MS2 bacteriophage | Sleep MODE | 4.9 log reduction | 45 minutes | | <i>Bacillus subtilis</i><br>endospores | Turbo MODE | 4.4 log reduction | 20 minutes | | <i>Bacillus subtilis</i><br>endospores | Sleep MODE | 4.3 log reduction | 60 minutes |
    Device Description
    Oorda OD1 is a freestanding medical recirculation air cleaner that facilitates movement with wheels. The device includes two pre-filters, two deodorizing filters, two HEPA filters - 3 filters in the front panel and 3 filters in the rear panel), and a manual for users. The device can adjust the air volume in four stages through manual operation (Level 1, Level3, Turbo) and Sleep mode. When operating in sleep mode, the equipment LED and PlasmaWave are turned off and operated with low noise. The device contains the following additional functions. (1)Child lock: Button lock function that prevents children or pets from changing their current motion mode even if they accidentally operate device. (2)Filter Replacement Guide: The remaining filter life is displayed on the front display of the device and tells you when to replace the filter. (3)Adjustment of illuminance: You can adjust the illuminance in four stages (100%, 50%, 20%, OFF). (4)You can turn on or off the PlasmaWave. (5)The timer allows the equipment to turn off automatically after a certain period of time. Qorda QD1 inhales air in both directions on the front and rear of the device and purifies it through the four cleaning steps below: [Pre-Filter] The air is drawn in through the cover front, passes through the Pre-Filter then moves to two filters stages(CD Carbon Filter, True HEPA Filter). The Pre-Filter protects CD Carbon Filter, True HEPA Filter inside the Pre-Filter. [CD Carbon Filter] Reduces any ozone generated as a byproduct of the plasma field. It also prolongs the True HEPA Filter lifespan. [True HEPA Filter] True HEPA Filter captures 99.99%* of airborne ultrafine particles as small as 0.003 microns. *Based on independent laboratory test conducted on particles as small as 0.003 microns in size. [PlasmaWave] PlasmaWave Technology has been tested by an independent third-party to remove particles from the air for medical purposes.
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    K Number
    K220298
    Device Name
    CerroZone Mobile
    Manufacturer
    CerroZone
    Date Cleared
    2022-07-01

    (149 days)

    Product Code
    FRF
    Regulation Number
    880.5045
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CerroZone Mobile is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles (i.e., bacteria and viruses) from the air for medical purposes.
    Device Description
    The CerroZone Mobile is a medical recirculating air cleaner that uses multiple inactivation processes consisting of reactive oxidizing species (ozone) and ultraviolet radiation to inactivate bacteria and viruses in the air. The CerroZone Mobile may be used in medical facilities. Once turned on, inlet air is passed through CerroZone Mobile's inline flow-through design which inactivates bacteria and viruses in a single pass flow-through. The device generates 220 cubic feet of air per minute (CFM), or 2.36 air changes per hour (ACH) in a standard 5,600 cu. Ft room. This process of air being inlet, purified, then outlet, lasts approximately 1.2 seconds. A 4 LOG reduction of airborne particles in a standard 579 cu. Ft room is achieved in 30 minutes or less. A 5.67 LOG, or 99.9998%, reduction is achieved in 45 minutes or less.
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    K Number
    K213114
    Device Name
    BentrioTM Allergy Blocker
    Manufacturer
    Altamira Therapeutics, Inc.
    Date Cleared
    2022-06-24

    (270 days)

    Product Code
    NUP
    Regulation Number
    880.5045
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bentrio™ is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, animal hair and dust mites. Application of Bentrio™ produces a mucous-like gel barrier that coats the nasal membranes, traps inhaled allergens within the nasal cavity and helps with their clearance.
    Device Description
    Bentrio™ is a gel emulsion which is applied as a nasal spray for self-protection. It is intended to help protect against allergens such as pollen, house dust, animal hair and dust mites, which are inhaled through your nose and may cause allergic reactions. Bentrio™ is free of any medication such as antihistamines or steroids and does not contain any preservatives. The gel formulation of Bentrio™ has been designed for extended residence time within the nose. Upon shaking of the spray bottle, it turns liquid which allows for spraying into the nose. After contact with the nasal mucosa, the formulation returns to its gel state and creates the protective barrier. Bentrio™ is cleared from the nasal cavities over time into the throat and eliminated via the digestive tract.
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    K Number
    K201734
    Device Name
    AllerBlock Junior
    Manufacturer
    Nasaleze International Ltd
    Date Cleared
    2021-03-26

    (274 days)

    Product Code
    NUP
    Regulation Number
    880.5045
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AllerBlock Junior is intended for use in adults and children (8 years or older) to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor environmental pollens, house dust, animal hairs, and dust mites. Application of AllerBlock Junior produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.
    Device Description
    AllerBlock Junior is composed of pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC; 97%) and high quality strawberry scent (3%) which has been formulated into a micronized powder of fine particles of inert cellulose. AllerBlock Junior is administered by insufflation into the nose using a proprietary spray bottle which enables the powder to be applied evenly as a fine mist to the inside of the nasal cavity. When the powder comes into contact with the moist surface of the nasal mucosa, it almost immediately forms a colorless, mucus-like fine gel which coats the inside of the nasal cavity. The inert gel acts as a mechanical barrier -- making it more difficult for inhaled allergens to come into contact with the skin in the nasal interior, and thus reducing the intensity of allergic rhinitis (AR) symptoms.
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    K Number
    K200321
    Device Name
    Novaerus NV1050
    Manufacturer
    Novaerus US Inc
    Date Cleared
    2020-12-28

    (322 days)

    Product Code
    FRF
    Regulation Number
    880.5045
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Novaerus NV 1050 is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes.
    Device Description
    The Novaerus NV1050 (NV1050) is a free-standing cabinet of a size that can be maneuvered into position by a single person. The NV1050 is powered from an AC wall outlet. The NV1050 circulates the room air through its cabinet. The air is drawn in through the front of the cabinet, passes through a pre-filter then a Dielectric Barrier Discharge Plasma generator ("plasma generator") stage, and a further two filters (HEPA, Carbon) The cleaned air is exhausted out of the top panel of the cabinet. The device has simple controls: On/Off and fan speed setting from 1 to 5. There is a button to initiate a filter blockage test to check and inform the user if the filters are getting close to requiring changing. The only routine maintenance is a calendar-based filter change schedule indicated in the User Manual; the indicator light on the front panel acts as a reminder that the filters will soon need attention. The airflow path through the NV1050 is: - A general pre- filter to remove particles from the input air flow. . - A bank of three (3) plasma generators, each Plasma Generator consists of ● two (2) plasma Coils. Micro-Organisms, including virus and bacteria, are inactivated by the plasma generator. This occurs through damage by plasma constituents (ions, electrons, reactive oxidizing species, ultraviolet radiation, high electric fields) - A HEPA (High-efficiency Particulate Air) filter to trap the resulting virus/bacteria particulates. - . An activated carbon filter to trap any ozone in the airstream before it is output to the environment.
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