RGS; RGS Mini

K222702 · Genesis Air, Inc. · FRA · Jun 2, 2023 · General Hospital

Device Facts

• Record ID: K222702
• Device Name: RGS; RGS Mini
• Applicant: Genesis Air, Inc.
• Product Code: FRA · General Hospital
• Decision Date: Jun 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. The RGS / RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions. The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3. This device is not intended for use in areas with a sterile field or controlled air flow.

Device Story

Medical ultraviolet air purifier; uses MERV 13 filter for particle filtration; incorporates PCO component consisting of TiO2-coated mesh and UV-C lamps (approx. 254 nm). Air drawn through device by centrifugal fan; UV-C light activates TiO2 photocatalyst to deactivate microorganisms/viruses via chemical reaction. Used in general hospitals, schools, hotels, restaurants, casinos; operated by healthcare professionals or lay users via manual knob for fan speed control. Output is purified air; benefits patient by reducing airborne bacterial/viral load. Safety features include analog switches on filter doors to prevent UV exposure and fan contact. Device is free-standing or wall-mounted.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via laboratory testing (LMS Technologies) demonstrating log 4 reduction of Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in 60 minutes. Electrical safety and EMC testing performed per UL 507 and IEC 60601-1-2.

Technological Characteristics

Materials: Galvanized steel frame, fiberglass/titanium-enriched catalyst mesh. Sensing/Actuation: Analog fan speed control, analog safety switches. Energy: 120 VAC, 60 Hz. UV Source: Mercury vapor lamps (254 nm). Dimensions: RGS (15"x16.25"x33.25"), RGS mini (19"x15"x15"). Connectivity: None. Sterilization: N/A (air purification). Software: None.

Indications for Use

Indicated for medical purposes to destroy bacteria in the air via ultraviolet radiation. Not for use in sterile fields or controlled air flow areas. Suitable for use by healthcare professionals and lay users in general hospital, school, hotel, restaurant, and casino environments.

Regulatory Classification

Identification

A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.

Predicate Devices

• Aura Storm, Invictus Lighting (K212644)

Submission Summary (Full Text)

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June 2, 2023

Genesis Air, Inc. % Dan Briggs President www.genesisair.com 5202 Country Road 7350, Suite D Lubbock, Texas 79424 Phone Number: [phone]

Re: K222702

Trade/Device Name: RGS: RGS Mini Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: June 1, 2023 Received: May 5, 2023

Dear Dan Briggs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Christopher K. Dugard -S

for Clarence W. Murray, III, Ph.D. Assistant Director THT4B1:Sterility Devices Team DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Center for Devices and Radiological Health U.S. Food and Drug Administration

Enclosure

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# Indications for Use

510(k) Number (if known) K222702

Device Name RGS / RGS mini

#### Indications for Use (Describe)

The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.

The RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions.

The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.

This device is not intended for use in areas with a sterile field or controlled air flow.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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Genesis Air, Inc. Traditional 510(k) Premarket Submission RGS / RGS mini

### 510(k) Summary

### RGS / RGS mini

### K222702

#### 1. Submission Sponsor

As required by 21CFR§807.92(c)

Genesis Air, Inc.

#### 5202 Country Road 7350, Suite D

Lubbock, Texas 79424

United States of America

Phone Number: [phone]

Contact Person: Dan Briggs

Title: President

### 2. Submission Correspondent

Genesis Air, Inc.

5202 Country Road 7350, Suite D

Lubbock, Texas 79424

United States of America

Phone Number: [phone]

Contact Person: Connor Croak

Title: Engineer

Email: [e-mail]

#### 3. Date Prepared

6/1/2023

#### 4. Device Identification

| Trade/Proprietary Name: | RGS / RGS mini |
|-------------------------|----------------------------------|
| Common/usual Name: | Air Purifier |
| Classification Name: | Medical ultraviolet air purifier |
| Regulation Number: | 21 CR §880.6500 |
| Product Code: | FRA |
| Device Class: | Class II |
| Classification Panel: | General Hospital |

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### 5. Legally Marketed Predicate Device(s)

K212644, Aura Storm, Invictus Lighting

No reference devices were used in this submission.

### 6. Indication for Use Statement

The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.

The RGS / RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions.

The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.

This device is not intended for use in areas with a sterile field or controlled air flow.

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# 7. Device Description

The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.

The device uses a MERV 13 filter for particle filtration. Down upstream of the pre-filter is a PCO component. The PCO consists of a TiO2 coated mesh and UV lights. When the UV lights (UV-C) provide sufficient energy, the TiO2 coated photo catalyst is activated. This component will deactivate microorganisms and viruses through a chemical reaction.

The RGS / RGS mini model numbers RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions. The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.

# 8. Substantial Equivalence Discussion

The following table compares the RGS / RGS mini to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing.

Table 5A – Comparison of Characteristics

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iraditional ५३०५) rremarket supmission

RGS / RGS mini

| Manufacturer | Genesis Air, Inc. | Invictus Lighting, LLC | Device Comparison |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Trade Name | RGS / RGS mini | Invictus Aura Storm Air Purifier | |
| 510(k) Number | K222702 | K212644 | |
| Panel | General Hospital | General Hospital | |
| Product Code | FRA | FRA | |
| Regulation Number | 21 C.F.R. § 800.6500 | 21 C.F.R. § 800.6500 | |
| Regulation Name | Medical ultraviolet air purifier | Medical ultraviolet air purifier | |
| Class | II | II | |
| Rx/OTC | OTC | OTC | |
| User | Healthcare Professional<br>Lay User | Healthcare Professional<br>Lay User | Same |
| Environment of Use | General Hospital,<br>Public Schools,<br>Hotels,<br>Restaurants,<br>Casinos | Hospitals, medical<br>facilities,<br>medical clinics, nursing<br>facilities, and dental<br>facilities. | Same |
| User | Health Care<br>Professionals,<br>School Districts,<br>Hotels,<br>Restaurants, Casinos | Health Care<br>Professional, Lay User | Same |
| Installation | Free Standing and Wall Mount | Free Standing | |
| Indications for Use | The RGS / RGS mini is<br>a medical ultraviolet<br>air purifier that is<br>intended for medical<br>purposes. It is used<br>to destroy bacteria in<br>the air by exposure<br>to ultraviolet<br>radiation.<br>The RGS / RGS mini<br>have demonstrated<br>the ability to<br>eliminate<br>Staphylococcus<br>Epidermidis,<br>Bacteriophage MS2,<br>and Escherichia Coli<br>in the air of the test<br>chamber in 60<br>minutes under the<br>following conditions. | The Aura Storm air<br>purifier is a device<br>intended for medical<br>purposes that is used to<br>capture and destroy<br>bacteria and viruses in<br>the air through the<br>multi-stage filtration<br>system and exposure to<br>ultraviolet radiation.<br>The Aura Storm air<br>purifier has been<br>demonstrated to<br>destroy the following<br>bacteria: Staphylococcus<br>albicans,<br>Staphylococcus aureus,<br>and Escherichia Coli;<br>and virus: A/PR8/34<br>H1N1 virus entrained<br>on the filter of the<br>subject device under | Similar. The different<br>organisms for each<br>does not affect the<br>safety. |
| | The device with model<br>number RGS and a high<br>fan speed of 600 CFM<br>when tested against<br>Staphylococcus<br>Epidermidis (gram<br>positive) had a log<br>reduction of 4.0<br>PFU/ft^3. The device<br>with model number<br>RGS and a high fan<br>speed of 600 CFM<br>when tested against<br>Bacteriophage MS2<br>had a log reduction of<br>4.02 PFU/ft^3.The<br>device with model<br>number RGS and a high<br>fan speed of 600 CFM<br>when tested against<br>Escherichia Coli had a<br>log reduction of 4.24<br>PFU/ft^3. The device<br>with model number<br>RGS mini and a high<br>fan speed of<br>500 CFM when tested<br>against Staphylococcus<br>Epidermidis. This<br>device is not intended<br>for use in areas with a<br>sterile field or<br>controlled air flow. | the following exposure<br>conditions: Average<br>Maximum log<br>reduction/entrainment<br>time (minutes) at Fan<br>Speed 4. Room<br>Temperature test:<br>Log 4(99.99%) / 60<br>minutes. Average<br>Maximum log<br>reduction / entrainment<br>time (minutes) at Fan<br>Speed 1. Room<br>Temperature test: Log 4<br>(99.99%) / 120 minutes | |
| System Components | - Pre-filter<br>- 6" TiO2 Coated<br>Photocatalyst<br>UV-C Lamp<br>(Approximately 254<br>nm) | - Pre-filter<br>- HEPA H13+ Filter<br>- TiO2 Photo Catalyst<br>Filter<br>UV-C Sterilization Lamp<br>(253.7 nm) | Similar. Does not<br>affect Safety |
| Mechanism of Action | UV light (UV-C) of<br>sufficient energy<br>activates the TiO2<br>coated photocatalyst<br>that deactivates<br>microorganisms and | UV light of sufficient<br>energy (UV-C)<br>activates a TiO2<br>lined photocatalyst<br>that destroys<br>microorganisms | Same |
| | chemical reaction. | entrained on the<br>filter through a<br>photochemical<br>reaction, plus the<br>addition of a pre-<br>filter and<br>HEPA filter. | |
| Material | Frame: Galvanized<br>Steel Catalyst Panel:<br>Fiberglass and<br>titanium enriched<br>coating. | N/A | |
| Temperature Control | N/A | N/A | |
| Shelf Life | 1 year warranty<br>Pre-filter changes<br>every 3 months.<br>UV lamp changes every<br>12,000 hrs. | Recommended<br>replacement of filers<br>and UV lamps | Same |
| Light Sources | UV-C Light Source:<br>Mercury Vapor<br>lamps<br>Wavelength: 254nm<br>RGS: (2) 20" UVC Lamps<br>RGS total UV Power: 36<br>watts RGS mini: (2) 12"<br>UVC lamps RGS mini<br>totals UV power: 14<br>watts | UV-C Light<br>Source: LED<br>Wavelength:<br>253.7nm<br>Total of (2)<br>UV-C tubes<br>Lamps: (1 per<br>side)<br>Total UV Power: 8.0<br>watts | Similar, testing<br>showed no safety or<br>efficacy concerns |
| User Control | One knob turns the<br>unit on and controls<br>the infinitely variable<br>fans speed. | The unit features a<br>capacitive touch button.<br>Control to operate the<br>On/Off, Fan speed (4<br>speeds), Auto mode, UV<br>lamp, Anion generator,<br>Child lock, Timer, Filter<br>reset. One button turns<br>the unit on and off. | Same |
| Software<br>Microprocessor | Analog Controls are<br>used to control the fan<br>speed. Analog safety<br>switches are used to<br>protect the user from<br>UV radiation and<br>impeller blade. | Basic Firmware, used to<br>turn the unit on, off, and<br>change fan speed. | NA |
| Battery Operated | Not applicable | Not applicable | |
| AC Powered | RGS: 120 VAC, up to | 120 VAC, 0.55 amps, Up | Same |
| | 3.40 amps and 408<br>watts<br>RGS mini: 120 VAC, up<br>to 3.02 amps and 363<br>watts. | to 65 watts | |
| | | | |
| Pre-Filter(s) | MERV 13 Filter is<br>used for particle<br>filtration upstream of<br>the PCO.<br>Dust Spot Efficiency:<br>89-90% Filter<br>Dimensions:<br>RGS: 12" x 24" x 4"<br>RGS mini : 12" x 12" x<br>2" | Synthetic screen<br>mesh type added<br>prior to HEPA.<br>Designed to trap larger<br>particles and keep<br>them out of the HEPA.<br>Dimensions: 14 in x 15<br>in x 0.125 in | Same except for<br>proprietary<br>components. |
| HEPA Filer | HEPA Filter (Optional)<br>12" x 24"<br>x 6" | MERV 13<br>Dimensions: 14" x 15" x<br>0.125" | Similar, No Safety<br>Concerns. |
| Catalyst Mesh | Proprietary<br>Catalyst Media<br>Nominal<br>Dimensions:<br>RGS: 12" x 21" x 6"<br>RGS mini: 12" x 12" x<br>6" Photocatalyst<br>coated with<br>proprietary titanium<br>dioxide coating and<br>wire mesh. | Patent Pending Hybrid<br>Oxidizer with<br>proprietary Dual<br>action Catalyst.<br>Dimensions: N/A | |
| Photocatalyst | Proprietary Catalyst | Proprietary Catalyst | Same |
| Air Source | Centrifugal Fan | Centrifugal Fan | Same |
| Flow Source | Variable Fan<br>Speeds<br>RGS: 275 -<br>825 CFM<br>RGS mini: 300-500<br>CFM | 4 Speeds (low, medium<br>high, boost) and auto<br>mode provide up to 370<br>CFM | Same |
| Air Changes Per Hour<br>(ACH) | RGS: 3 ACH in a 16,000<br>ft³ Room RGS mini: 3<br>ACH in a 10,000 ft³<br>room. | 5.5 ACH on high fan<br>speed (Speed 4), in a<br>4,000 ft³ room. | Similar, no safety<br>concerns |
| Particulate Sensor | Not applicable | Not applicable | Same |
| UV Light Exposure<br>Safety Features | The Safety Switch is<br>located on the particle<br>filter door. If the<br>particle filter door is | There are two sets of<br>safety switches on the<br>Aura Storm. The first is<br>on both outer doors | Same |
| | | | |
| | open, then the device<br>will not operate. This<br>switch is in place to<br>protect the user from<br>UV light exposure and<br>exposure to the<br>moving fan wheel.<br>Safety features<br>confirmed by UL 507. | where the magnetic<br>switch will disengage,<br>and the unit will not turn<br>on. A secondary switch<br>in the Aura Storm filter<br>and if the filter is<br>improperly installed or<br>the filter is missing, the<br>unit will not operate.<br>The unit will not operate<br>with eh generic filter and<br>the Invictus filter must<br>be used for the system<br>to work. These witches<br>have been designed to<br>protect eh user<br>form any possibility of<br>exposure to direct<br>contact with UV light.<br>Safety features<br>confirmed by ETL to UL<br>507 safety standard. | |
| Fan Exposure Safety | The outlet grill protects<br>the user from being<br>able to access the<br>spinning fan wheel.<br>Inlet fan<br>grille protects user<br>from being able to<br>access the spinning fan<br>wheel. | Non-removable grill<br>at air output and<br>the switch safety<br>feature at the inlet<br>prevent the user<br>from accessing<br>spinning fan<br>without tools.<br>Safety feature<br>confirmed by ETL<br>tested to UL<br>507. | |
| Input Voltage | 120-volt single phase<br>AC power<br>at 60 Hz | 120-volt | |
| Current | RGS mini: up to 3.02<br>amps<br>RGS: up to 3.40 amps | 0.55 amps | |
| Power Consumption | RGS mini: up to 362<br>watts<br>RGS: up to 408 watts | Up to 65 watts | |
| Dimensions | RGS mini outer casing<br>dimensions: 19" x 15" x<br>15" | Outer frame<br>dimensions: 23 in<br>(H) x 18.2 in (W) x 10.6<br>in (L) | |
| Standards | x 12" x<br>2" Carbon Filter: 12" x<br>12" x 2"<br>HEPA Filter: 12" x<br>12" x 6" RGS casing<br>dimensions: 15" x<br>16.25" x 33.25"<br>Filter dimensions:<br>Standard Pre-filter: 12"<br>x 24" x 4"<br>Alternative Pre-filter:<br>12" x 24" x 2"<br>Carbon Filter: 12" x 24"<br>x 2" HEPA Filter: 12" x<br>24" x 6" | Filter dimensions:<br>Pre-Filter:<br>14 in x 15 in x 0.125 in<br>HEPA Filter:<br>14 in x 15 in x 0.6875 in<br>Catalytic Filter:<br>14 in x 15 in x 0.1875 in<br>Carbon/Cold<br>Catalyst Oxidizer<br>Filter: 14 in x 15in x<br>0.625 in | |
| | UL 507 Standard for<br>Electrical Fans IEC<br>60601-1-2 EMC<br>EMC for Medical<br>Devices…