Who is the manufacturer of Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

Devilbiss Healthcare, LLC filed the 510(k) submission for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator (K172648).

What is the FDA product code for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

CAW. It is classified under 21 CFR 868.5440 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

DeVilbiss iGo 306DS Portable Oxygen Concentrator (K081468).

Who can help prepare an FDA 510(k) submission like Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator

K172648 · Devilbiss Healthcare, LLC · CAW · Mar 23, 2018 · Anesthesiology

Device Facts

Record ID	K172648
Device Name	Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
Applicant	Devilbiss Healthcare, LLC
Product Code	CAW · Anesthesiology
Decision Date	Mar 23, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5440
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The Drive DeVilbiss iGo2 Portable Oxygen Concentrator is indicated for the administration of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities.

Device Story

Portable oxygen concentrator (POC) for home/institutional use; provides supplemental oxygen via pulse dose. Inputs: ambient air drawn via piston compressor. Principle: pressure-vacuum swing adsorption using two molecular sieve beds; nitrogen adsorbed under pressure, oxygen collected in product tank. Output: pulse-dose oxygen delivered to patient upon inhalation detection. Features 'Smart Dose' algorithm to automatically increase oxygen setting if patient breathing rate increases. Operated by patient or caregiver. Healthcare provider uses output to manage oxygen therapy; benefits patient by providing ambulatory oxygen support. Device includes LCD for status/alerts; powered by AC or DC/battery.

Clinical Evidence

No clinical testing performed. Substantial equivalence demonstrated via bench testing using patient simulation models to verify oxygen output, breathing detection, and compliance with ISO/IEC standards.

Technological Characteristics

Pressure-vacuum swing adsorption; lithium-based zeolite molecular sieve. Piston compressor. Pulse-dose delivery. Power: 100-240 VAC or 12-24 VDC. Dimensions: 9.6"H x 8.75"W x 3.6"D. Weight: <6 lbs. Connectivity: None. Standards: IEC 60601-1 (3rd Ed), IEC 60601-1-2, ISO 80601-2-69, ISO 80601-2-67, ISO 14971, ISO 13485. Software: Microprocessor-based control for valve timing, oxygen monitoring, and Smart Dose algorithm.

Indications for Use

Indicated for adult and pediatric patients (>10kg) requiring supplemental oxygen. Not for life support; no patient monitoring capabilities.

Regulatory Classification

Identification

A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

Predicate Devices

DeVilbiss iGo 306DS Portable Oxygen Concentrator (K081468)

Reference Devices

Model 350G Gas Conserver (K090421)

Related Devices

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K252268 — V series portable oxygen concentrator (V5, V5C, V6, V6C) · Shenzhen Harveymed Technology Co., Ltd. · Dec 16, 2025
K230702 — Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) · Qingdao Kingon Medical Science and Technology Co., Ltd. · Oct 18, 2023
K251130 — Portable Oxygen Concentrator (JM-P50A) · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Aug 21, 2025
K071928 — THE INVACARE FLYER, MODEL IPC 100 · Invacare Corp. · Dec 12, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the Food and Drug Administration logo. The FDA logo is in blue and contains the words "FDA U.S. FOOD & DRUG ADMINISTRATION". March 23, 2018 DeVilbiss Healthcare, LLC Sandy Figueroa Manager, Regulatory Affairs 100 DeVilbiss Drive Somerset, Pennsylvania 15501 Re: K172648 Trade/Device Name: Drive DeVilbiss iGo 2 Portable Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: February 19, 2018 Received: February 20, 2018 Dear Sandy Figueroa: 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. 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. 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K172648 Device Name Drive DeVilbiss iGo2 Portable Oxygen Concentrator Indications for Use (Describe) The Drive DeVilbiss iGo2 Portable Oxygen Concentrator is indication of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Name and address of the manufacturer and sponsor of the 510(k) submission: | DeVilbiss Healthcare LLC 100 DeVilbiss Drive Somerset, PA 15501 | |-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | Official contact person for all correspondence: | Betty Miller Regulatory/Compliance Manager Phone: 814-443-7606 Fax: 814-443-7575 | | Date Prepared: | March 22, 2018 | | Device Name: | Drive DeVilbiss iGo2 Portable Oxygen Concentrator | | Proprietary name of new device: | Drive DeVilbiss iGo2 Portable Oxygen Concentrator | | Common or usual name of the device: | Generator, Oxygen, Portable | | DeVilbiss Model Number | 125D, 125K, 125AA | | Classification | Class II | | Panel Code: | CAW | | CFR Regulation Number: | 21 CFR 868.5440 | | Primary Predicate Device Name and 510(k) number: | DeVilbiss iGo 306DS Portable Oxygen Concentrator (K081468) | | Reference Device Name and 510(k) number: | Model 350G Gas Conserver (K090421) | # Description of Device: The proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator (POC) is similar to the predicate devices, pressure-vacuum swing adsorption based on molecular sieve technology using two containers filled with molecular sieve (sieve beds). Ambient air is drawn into the concentrator via a piston style compressor and compressed into a single sieve bed. As pressure increases nitrogen is adsorbed and concentrated oxygen exits one end of the bed and is collected in a product tank. Simultaneously in the other sieve bed, nitrogen is desorbed as the pressure decreases to a vacuum and is exhausted into the atmosphere. Once the pressure or vacuum reaches a defined maximum a valve switches the compressor connections to the sieve beds. The sieve bed previously connected to the pressure head will be connected to vacuum. The oxygen collected in the product tank is then dispensed to the patient upon detecting a patient inhalation, much like an oxygen conserving device. The proposed Drive DeVilbiss iGo2 POC provides pulse dose oxygen in the same manner as primary predicate device (DeVilbiss Model 306 POC, K081468). The "Smart Dose" feature has been added to the proposed device, which is substantially equivalent to the feature in the reference device (Model 350G gas {4}------------------------------------------------ conserver, K090421). Smart Dose will automatically increase the patient's prescription setting by one if the system determines the patient has increased rate of breathing. This device is intended for Adult and Pediatric patients with a bodyweight >10kg. ## Indication for Use: The Drive DeVilbiss iGo2 Portable Oxygen Concentrator is indicated for the administration of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. ## Substantial Equivalence: The proposed (modified) Drive DeVilbiss iGo2 Portable Oxygen Concentrator has the following similarities to those which previously received 510(k) concurrence: - Indications for Use Statement - Operating Principle - Incorporates similar materials, and - Is manufactured and packaged using similar materials and processes. Design and verification activities were performed on the proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator according to design requirements and risk analysis outputs. All bench tests confirmed that the predetermined acceptance criteria were met. This includes oxygen output and breathing detection. {5}------------------------------------------------ ## Comparison of Substantial Equivalence and Differences: | Characteristics | Predicate Device DeVilbiss iGo 306DS Portable Oxygen Concentrator - K081468 | Reference Device Model 350G Gas Conserver K090421 | Subject Device | Nature of Change | Legally Marketed Product with same feature or specification | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | ltem Description/ Method of Operation | 1-3 lpm continuous flow (1-6 pulse dose), pressure-Vacuum swing adsorption, oxygen concentrator based on molecular sieve technology. Ambient air is drawn into the concentrator via a piston style compressor. The air then passes through a series of filters that remove dust, bacteria, and other particulate. A poppet-style valve directs air into one of two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases while oxygen flows through, thereby producing a highly enriched oxygen product. Simultaneously in the other bed, nitrogen is absorbed as the pressure decreases and is exhausted into the atmosphere. A momentary intermediate pneumatic sequence ties the beds together with the exhaust blocked for an enhanced nitrogen purge. The cycle continues providing a flow of oxygen to the patient. Oxygen is provided to the patient on a continuous or pulse-dose basis. | The Inspired Technologies 350G Gas Conserver is intended as a delivery device for medial-grade oxygen from high- pressure oxygen cylinders. | (1-5 pulse dose), pressure- Vacuum swing adsorption, oxygen concentrator based on molecular sieve technology. Ambient air is drawn into the concentrator via a piston style compressor. The air then passes through a series of filters that remove dust, bacteria, and other particulate. A valve directs air into one of two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases while oxygen flows through, thereby producing a highly enriched oxygen product. Simultaneously in the other bed, nitrogen is absorbed as the pressure decreases and is exhausted into the atmosphere. A momentary intermediate pneumatic sequence ties the beds together with the exhaust blocked for an enhanced nitrogen purge. The cycle continues providing oxygen to the patient. Oxygen is provided to the patient on a pulse-dose basis. | Minor constructional differences. POC will be smaller and not support continuous flow. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Target Population/ Indications for Use | The Model 306 Portable Oxygen Concentrator is indicated for the administration of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. | This is an ambulatory device, which allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. | The Portable Oxygen Concentrator is indicated for the administration of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. | Same. Provides pulse oxygen to patient. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Where Used/ Intended Use | Oxygen concentrators are intended to provide supplemental oxygen to persons requiring low flow oxygen therapy. The patient typically receives the oxygen through a nasal cannula. The device delivers continuous oxygen or oxygen pulses during a patients inhalation phase. The pulse flow provides over 87% oxygen concentration. It is used at a patient's home or for their portable needs outside the home and can also be used in institutions such as nursing homes or sub-acute care facilities. Oxygen concentrators are not considered life supporting nor life sustaining. The device has no contraindications. | The 350G Gas Conserver is intended to be used in the hospital, healthcare facilities, or home care environments. | Oxygen concentrators are intended to provide supplemental oxygen to persons requiring low flow oxygen therapy. The patient typically receives the oxygen through a nasal cannula. It is used at a patient's home or for their portable needs outside the home and can also be used in institutions such as nursing homes or sub-acute care facilities. Oxygen concentrators are not considered life supporting nor life sustaining. The device has no contraindications. | Same. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator - K081468 | | Characteristics | Predicate Device DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | Reference Device Model 350G Gas Conserver K090421 | Subject Device | Nature of Change | Legally Marketed Product with same feature or specification | | Operating Principle | Pressure-vacuum-swing adsorption / pressure controlled oxygen separation process | Integral high pressure regulator Dosing device and algorithm Valves | Pressure-vacuum-swing adsorption / pressure controlled oxygen separation process | Same as iGo 306DS. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Standards Certification | IEC 60601-1 2nd Edition IEC 60601-1-1 IEC 60601-1-2 ISO 8359 ISO 14971 ISO 13485 | FCC CFR47 Parts 15B and 18 Industry Canada BS EN 55011:2007 IEC 60601-1 IPX I | IEC 60601-1 3rd Edition IEC 60601-1-1 IEC 60601-1-2 ISO 80601-2-69 ISO 80601-2-67 ISO 14971 ISO 13485 | New device conforms to newer revisions of standards. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Output Capacity and Delivery Modes | 3 LPM maximum continuous flow. Continuous flow settings: 1 to 3.0 LPM in 0.5 LPM increments Pulse flow settings: 1.0 to 3.0 in 0.5 increments; 3.0 to 6.0 in 1.0 increments | 16.0 cc/lpm x setting value( i.e. 16x 1=16, 16 x 2 =32 etc) at 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, and 6.0 Lpm flow settings Sport mode I is setting value + 16 cc Sport Mode 2 is setting value +32 cc/lpm | Pulse flow settings: 1.0 to 5.0 in 1.0 increments | Does not support Continuous flow. Pulse mode like iGo 306DS but supports a smaller set of the patient population because of smaller bolus volume. Supports Smart Dose (Sport Mode) | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 Model 350G Gas Conserver K090421 | | Voltage Required | AC operation: 100-240 VAC, 50-60 Hz DC operation: 12-24 VDC | 4 "AA" batteries | AC operation: 100-240 VAC, 50-60 Hz DC operation: 10 - 15 VDC | Minimal difference. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator — K081468 | | Dimensions | 15"H x 12"W x 9"D Cube volume: 1620 cu. in. | 6"H x 3.5"W x 4"D | 9.6"H x 8.75"W x 3.6"D Cube volume: 302.4 cu. in. | Smaller more portable device than iGo 306DS. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator - K081468 | | Weight | 17.9 lbs, including battery, 19.9 lbs with lightweight cart | 1.39 lbs | Less than 6 lbs, including a standard battery pack. | Lighter more portable device than iGo 306DS. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | 02 Performance Specification | 90% +/-3% at 1 Ipm to 3 Ipm at sea level | N/A - Uses bottled gas | 87-94% at all settings | Same as iGo 306DS. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator - K081468 | | Noise Level @ 2 Ipm | 40 dBA at pulse flow setting 3; 47 dBA overall maximum at 3 LPM continuous flow | N/A – Uses bottled gas | 46 dBA at pulse flow setting 2 | Louder than iGo 306DS but no different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator - K081468 | | Power Consumption | 42 Watts at 1.0 LPM continuous flow 104 Watts at 3.0 LPM continuous flow 31 Watts at 1.0 pulse flow setting (20 BPM) 62 Watts at 6.0 pulse flow setting (20 BPM) | | Approximately 30 Watts at setting of 2 (20 BPM) | Pulse dose efficiency is better. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Characteristics | Predicate Device DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | Reference Device Model 350G Gas Conserver K090421 | Subject Device | Nature of Change | Legally Marketed Product with same feature or specification | | Patient Oxygen Outlet Pressure | 5 psig | 19-25 PSIG | 15 psig | Higher pulsed output pressure than iGo but lower than 350G. Will deliver oxygen faster than iGo but there is no different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Filtration | Patient-maintainable gross particle filter | None | Gross particle filter | Same as iGo 306DS. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Battery Run Time | Tested times: 4.1 hours at 1.0 LPM 1.7 hours at 3.0 LPM 5.8 hours at 1.0 LPM (10 BPM) 2.0 hours at 6.0 LPM (30 BPM) | NA | 4.5 hours at a setting of 2 (20 BPM) | Same as iGo 306DS at equivalent pulse output. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Compressor Pressure Relief Valve | Pressure Relief valve | NA | Over-pressure protection achieved through software and electronic control. | No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Pneumatic Valve | Two Three way valves | NA | Two Three way valves | Off the shelf valves – No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Molecular Sieve Material | Zeochem lithium-based zeolite | NA | Zeochem lithium-based zeolite | Same as iGo 306DS. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Flow Controller | Proportional control valve used for continuous flow and pulse flow | Pulse Valve | Pulse Valve only. Use software to regulate output. | Same as iGo 306DS. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Insulation Class | IEC Class 1, Type BF | Not Published | IEC Class 2, Type BF | Improved required by ISO standard. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Water Ingress | IPX0 – bare unit IPX1 – Unit with battery | IPX1 | IPX1 Or IPX22 | Improved liquid ingress capability. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Hour meter | Mechanical Hour meter | None | Microprocessor or other nonvolatile memory. | Used for service and dealer. No different questions of safety or effectiveness. | DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | | Characteristics | Predicate Device DeVilbiss iGo 306DS Portable Oxygen Concentrator – K081468 | Reference Device Model 350G Gas Conserver K090421 | Subject Device | Nature of Change | Legally Marketed Product with same feature or specification | | Oxygen Monitor | Ultrasonic oxygen and flow sensing device (FDA approved Re: K913392/B)…