EMMA® Capnograph measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.

Device Description

The subject device, EMMA® Capnograph (EMMA), the same as the predicate, is a portable medical device capable of measuring, displaying, and monitoring carbon dioxide and respiratory rates from exhaled air. The difference between the subject device and the predicate device is the addition of the wireless capability to allow for the wireless transmission of data. The intended use and measurement functions have not changed from the previous clearance.

AI/ML Overview

Masimo Corporation sought 510(k) clearance for their EMMA Capnograph with added wireless capabilities. The device measures and monitors carbon dioxide partial pressure and respiratory rates for adult, pediatric, and infant patients across various clinical settings.

Here's an analysis of the acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (EMMA Specification)	Reported Device Performance (Subject Device)
CO2 Accuracy	0-40 mmHg: +/- 2 mmHg	0-40 mmHg: +/- 2 mmHg (Same as predicate)
	41-99 mmHg: 6% of reading	41-99 mmHg: 6% of reading (Same as predicate)
Respiration Rate Accuracy	3-150 breaths/min: $\pm$ 1 breaths/min	3-150 breaths/min: $\pm$ 1 breaths/min (Same as predicate)
Total System Response Time	< 0.7 s	< 0.7 s (Specification met)
Operating Temperature	-5 to 50 °C (23 to 122 °F)	-5 to 50 °C (23 to 122 °F) (Same as predicate)
Storage/Transport Temperature	-40 to 70 °C (-40 to 158 °F)	-40 to 70 °C (-40 to 158 °F) (Extended from predicate: -30 to 70 °C, and verified. Test supports acceptability of lower temperature specification.)
Operating Humidity	10 - 95%, non-condensing	10 - 95%, non-condensing (Same as predicate)
Storage/Transport Humidity	10 - 95%, non-condensing	10 - 95%, non-condensing (Narrowed from predicate: 5 - 100%, and verified.)
Operating Atmospheric Pressure	60 - 120 kPa	60 - 120 kPa (Extended from predicate: 70 - 120 kPa, and verified. Test supports acceptability of lower atmospheric pressure specification.)
Electrical Safety/EMC	IEC 60601 compliant	IEC 60601-1-2:2014 compliant (Testing supports addition of wireless radio capabilities does not impact essential performance.)
Wireless Communication	Supports Bluetooth wireless communication	Bluetooth GFSK, 2402-2480 MHz, Max Peak Output Power -1 dBm, Antenna Peak Gain -7 dBi, Recommended Range ~10 feet (~3 meters) line-of-sight (Added capability, tested for radio co-existence).
Radio Co-existence	Quality of service of wireless connection maintained under normal and anticipated abnormal conditions	Testing supports the quality of the service of the wireless connection is maintained under normal and anticipated abnormal conditions.
Cybersecurity	Acceptable cybersecurity risks	Testing supports the acceptability of the cybersecurity risks.

Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the test sets used in the engineering verification and validation. The studies mentioned (EMC, radio co-existence, cybersecurity, operational verification for temperature and atmospheric pressure) are typically engineering validation tests performed on the device itself, rather than clinical studies using human subjects or large datasets. As such, the data provenance is from laboratory testing of the manufactured device.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The ground truth for the engineering tests would be established by reference standards or highly calibrated equipment used for performance verification (e.g., precise gas mixtures for CO2 accuracy, controlled temperature/pressure chambers, standardized EMC/wireless testing setups).
Adjudication Method for the Test Set:
Not applicable. These are engineering performance tests, not studies requiring expert adjudication of clinical outcomes.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. The submission focuses on substantial equivalence based on engineering changes (addition of wireless capabilities) to an already cleared predicate device, rather than a new clinical comparison.
Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
While the EMMA Capnograph functions as a standalone device, the document does not detail a "standalone algorithm only" study in the context of AI without human interaction. The performance criteria listed (e.g., CO2 accuracy, respiration rate accuracy) inherently represent the standalone performance of the device's measurement functions. The core measurement algorithm itself has not changed from the predicate.
Type of Ground Truth Used:
For the CO2 and respiration rate accuracy, the ground truth would be established by controlled gas mixtures with known CO2 concentrations and controlled respiration rates simulated in a laboratory setting, using highly accurate reference measurement systems. For environmental and electrical tests, ground truth is defined by established international standards (e.g., IEC 60601-1-2) and highly calibrated testing equipment.
Sample Size for the Training Set:
Not applicable. This device is not an AI/Machine Learning device that requires a training set in the typical sense. It relies on established physical principles of infrared light absorption.
How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.

Summary

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March 29, 2021

Masimo Corporation Katelynn Kirby Regulatory Affairs Specialist III 52 Discovery Irvine, California 92618

Re: K201590

Trade/Device Name: EMMA Capnograph Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: February 26, 2021 Received: March 2, 2021

Dear Katelynn Kirby:

We have reviewed vour 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 af fecting 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 equi valence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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) 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K201590

Device Name EMMA Capnograph

Indications for Use (Describe)

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)

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ION

510(k) Summary K201590

Submitter and Address ofManufacturing Facility:	Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7000FAX: (949) 297-7592
Date:	June 11 2020
Contact:	Katelynn KirbyRegulatory Affairs Specialist IIIMasimo CorporationPhone: (949) 297-7408
Trade Name:	EMMA Capnograph
Common Name:	Carbon Dioxide Gas Analyzer
Classification Regulation:	21 CFR 868.1400, Class II
Product Code:	CCK
Establishment RegistrationNumber:	3011353843
Reason for PremarketNotification:	Addition of Wireless Capabilities
Predicate Device:	K072813 - EMMA Emergency Capnometer
Performance Standards	No performance standards for the above device have beenpromulgated pursuant to Section 514.

5.1. Device Description

Feature	EMMA Specification
General
Display type	Integrated Visual Display
Airway Adapter Adult/Pediatric	Single patient use proprietary airway adapter, 6 cc dead space.
Airway Adapter Infant	Single patient use proprietary airway adapter, 1 cc dead space.
Performance Specifications
CO2	0-40 mmHg: +/- 2 mmHg.

The specifications for EMMA are as follows:

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ATION

510(k) Summary K201590

Feature	EMMA Specification
Respiration Rate (3-150 breaths/min)	41-99 mmHg: 6% of reading$\pm$ 1 breaths/min
Total System Response Time	< 0.7 s
Displays/ Indicators
Data displayed	CO2, Respiration Rate
Alarm	No Breath Detected, No Adapter, Check Adapter,Low battery, Low / High ETCO2 with adjustable alarm limits.
Electrical
Internal battery power	2 "AAA" Batteries
Output Interface
Wireless Output	Supports Bluetooth wireless communication
Mechanical
Enclosure Material	Thermoplastic
Dimensions	52 x 39 x 39 mm (2.1 x 1.5 x 1.5 inches)
Weight	65 g (2.1 oz) with batteries
Environmental
Operating Temperature	-5 to 50 °C (23 to 122 °F)
Storage/Transport Temperature	-40 to 70 °C (-40 to 158 °F)
Operating Humidity	10 - 95%, non-condensing
Storage/Transport Humidity	10 - 95%, non-condensing
Operating Atmospheric Pressure	60 - 120 kPa
Compliance
Electrical Safety/EMC	IEC 60601 compliant
Type of Protection	Internally powered
Degree of Protection	Defibrillation proof, BF-applied part
Degree of Ingress Protection	IP44
Mode of Operation	Continuous operation
Wireless Specifications
Type	Bluetooth GFSK
Frequency	2402-2480 MHz
Max Peak Output Power	-1 dBm
Antenna Peak Gain	-7 dBi
Recommended Range	~10 feet (~3 meters) line-of-sight

Intended Use/ Indications for Use 5.2.

5.3. Technological Characteristics

Principle of Operation

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Image /page/5/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold font. To the right of the word "Masimo" is the text "MASIMO CORP" followed by the address "52 Discovery, Irvine, CA 92618".

The measurement of CO2 in the breathing gas mixture is based on the fact that different gas components absorb infrared light at specific wavelengths. A beam of invisible infrared light is directed through the respiratory gas flow in the EMMA Airway Adapter. As the beam passes through the airway adapter, some of the light is absorbed by the gas mixture. The amount of absorbed light is measured by a miniaturized two channel spectrometer positioned to receive the infrared light beam.

The spectrometer incorporates two different optical "color" filters. The wavelength ranges of these filters are chosen such that one filters out wavelengths where carbon dioxide has very strong absorption and the other filters out wavelengths where carbon dioxide has no absorption.

The spectrometer also incorporates an infrared detector that converts the light beam to an electrical signal. The electrical signal is converted to a digital value that is fed to a microprocessor. The ratio of the light measured through the two filters is then used by the microprocessor to calculate the carbon dioxide concentration in the breathing gas mixture.

Mechanism of Action for Achieving the Intended Effect

The EMMA works by attaching the EMMA Airway adapter between the endotracheal tube and resuscitation bag. The EMMA Airway Adapter once connected to the EMMA monitor becomes the path in which the breathing gas mixture passes. As the breathing gas mixtures passes, the infrared light passes through the light window provided in the adapter. The light window of the adapter aligns on the side with the infrared source and the other side with infrared detector. Based upon the amount of light absorbed when the different filters are in place, a CO2 and respiration rate is displayed on the EMMA monitor.

The EMMA Capnograph snaps in place on top of the EMMA Airway Adapter. The airway adapter may then, for example, be inserted between the endotracheal tube and the resuscitation bag or between the resuscitation bag and the patient mask.

Respiratory gas measurements are, as described in the previous section, obtained by continuously measuring the infrared light absorption through the "XTP Windows" that are transparent to light in the wavelength ranges of interest.

The Airway Adapters are fully sealed, except for the breathing circuit couplings. The breathing circuit couplings conform to existing standards for this type of couplings. The EMMA Sensor Body (reusable portion) does not come in contact with breathing circuit gases or the patient.

5.4. Summary of Technological Characteristics of Subject Device Compared to Predicate Device

The subject device incorporates a wireless module and a software modification to enable the radio and support the wireless communication of measurement data from EMMA.

There is no change to the intended use as part of this modification.

5.4.1 Similarities and Differences between Predicate and Subject Device

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Image /page/6/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CO" followed by the address "52 Discovery, Irvine, CA 92618".

The subject device, EMMA with wireless capabilities, and the predicate device, have the following key similarities:

· Both devices have the same intended use;
· Both devices have the same indicated populations;
· Both devices have the same measurement technology:
· Both devices have the same form factor

The subject device, EMMA with wireless capabilities, and the predicate device, have the following key differences:

· Subject device includes the ability to wirelessly communicate
· Subject device has a lower storage/transport specification

The purpose of this submission is the addition of the wireless capabilities to the EMMA. As part of the wireless function implementation, a radio module was incorporated into the hardware design and the software was updated to enable the wireless communication. There was no change to the measurement functions or the intended use of the device.

To support the wireless capabilities do not raise different questions of safety and effectiveness, the subject device was evaluated for electromagnetic compatibility testing to the latest IEC 60601-1-2 standard, radio co-existence testing, and cybersecurity risk mitigations.

The testing conducted supported the subject device to be substantially equivalent to the predicate device. Both devices have the same intended use and that the addition of the wireless capabilities does not raise different questions of safety and effectiveness.

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Image /page/7/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

Feature	EMMA Capnograph with wireless capabilities(Subject Device)	EMMA Emergency Capnometer (Predicate device)	Comparison
510(k) Number	Pending	K072813
General Information
Classification	21 CFR 868.1400, Class II	21 CFR 868.1400, Class II	Same
Product Code	CCK	CCK	Same
Indications for Use	EMMA® Capnograph measures, displays and monitorscarbon dioxide partial pressure and respiratory rateduring anesthesia, recovery and respiratory care. It maybe used in the operating suite, intensive care unit, patientroom, clinic, emergency medicine and emergencytransport settings for adult, pediatric and infant patients.	The EMMA Emergency Capnometer Monitor measures,displays and monitors carbon dioxide concentration andrespiratory rate during anesthesia, recovery andintensive care unit, patient room, clinic, emergencymedicine and emergency transport settings for adult,pediatric and infant patients.	Similar, carbon dioxideconcentration clarified ascarbon dioxide partialpressure.
Principle ofOperation	The measurement of CO2 in the breathing gas mixture isbased on the fact that different gas components absorbinfrared light at specific wavelengths. A beam ofinvisible infrared light is directed through the respiratorygas flow in the EMMA Airway Adapter. As the beampasses through the airway adapter, some of the light isabsorbed by the gas mixture. The amount of absorbedlight is measured by a miniaturized two channelspectrometer positioned to receive the infrared lightbeam.The spectrometer incorporates two different optical"color" filters. The wavelength ranges of these filters arechosen such that one filters out wavelengths wherecarbon dioxide has very strong absorption and the otherfilters out wavelengths where carbon dioxide has noabsorption.The spectrometer also incorporates an infrared detector	The measurement of CO2 in the breathing gas mixture isbased on the fact that different gas components absorbinfrared light at specific wavelengths. A beam ofinvisible infrared light is directed through the respiratorygas flow in the EMMA Airway Adapter. As the beampasses through the airway adapter, some of the light isabsorbed by the gas mixture. The amount of absorbedlight is measured by a miniaturized two channelspectrometer positioned to receive the infrared lightbeam.The spectrometer incorporates two different optical"color" filters. The wavelength ranges of these filters arechosen such that one filters out wavelengths wherecarbon dioxide has very strong absorption and the otherfilters out wavelengths where carbon dioxide has noabsorption.The spectrometer also incorporates an infrared detector	Same
	that converts the light beam to an electrical signal. Theelectrical signal is converted to a digital value that is fedto a microprocessor. The ratio of the light measured	that converts the light beam to an electrical signal. Theelectrical signal is converted to a digital value that is fedto a microprocessor. The ratio of the light measured
	through the two filters is then used by themicroprocessor to calculate the carbon dioxideconcentration in the breathing gas mixture.	through the two filters is then used by themicroprocessor to calculate the carbon dioxideconcentration in the breathing gas mixture.
Display
Display type	Integrated visual display	Integrated visual display	Same
Airway AdapterAdult/Pediatric	Single patient use proprietary airway adapter, 6 cc dead space.	Single patient use proprietary airway adapter, 6 cc dead space.	Same
Airway AdapterInfant	Single patient use proprietary airway adapter, 1 cc dead space.	Single patient use proprietary airway adapter, 1 cc dead space.	Same
Technological Characteristics EMMA
Display/Indicators
Data displayed	CO2, Respiration Rate	CO2, Respiration Rate	Same
Alarm	No Breath Detected, No Adapter, Check Adapter,Low battery, Low / High ETCO2 with adjustablealarm limits.	No Breath Detected, No Adapter, Check Adapter,Low battery, Low / High ETCO2 with adjustablealarm limits.	Same
Accuracy
CO2	0-40 mmHg: +/- 2 mmHg,41-99 mmHg: 6% of reading	0-40 mmHg: +/- 2 mmHg,41-99 mmHg: 6% of reading	Same
Respiration rate	3-150 breaths/min $\pm$ 1 breaths/min	3-150 breaths/min $\pm$ 1 breaths/min	Same
Environmental
Operating Temperature	-5 to 50 °C (23 to 122 °F)	-5 to 50 °C (23 to 122 °F)	Same
Storage/Transport Temperature	-40 to 70 °C (-40 to 158 °F)	-30 to 70 °C (-22 to 158 °F)	Subject DeviceStorage/TransportTemperature Extended to-40 to 70 °C
Operating Humidity	10 - 95%, non-condensing	10 - 95%, non-condensing	Same
Storage/Transport Humidity	10 - 95%, non-condensing	5 - 100%, non-condensing	Subject DeviceStorage/Transportnarrowed to 10 - 95%
Operating Atmospheric Pressure	60 - 120 kPa	70 - 120 kPa	Subject DeviceOperating AtmosphericPressure extended to 60 -
			120 kPa
Mechanical
Enclosure Material	Thermoplastic	Thermoplastic	Same
Dimensions	52 x 39 x 39 mm (2.1 x 1.5 x 1.5 inches)	52 x 39 x 39 mm (2.1 x 1.5 x 1.5 inches)	Same
Weight	65 g (2.1 oz) with batteries	65 g (2.1 oz) with batteries	Same
Electrical
Battery power	Internal battery power with 2 "AAA" Batteries	Internal battery power with 2 “AAA” Batteries	Same
I/O Interface
Wireless	Bluetooth	None	Subject device is providedwith additional Bluetoothwireless communicationcapabilities.
Mode of Operation
Mode of operation	Continuous	Continuous	Same

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Image /page/8/Picture/1 description: The image shows the Masimo Corporation logo. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

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Image /page/9/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" in a smaller, lighter font, followed by the address "52 Discovery, Irvine, CA 92618".

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Image /page/10/Picture/2 description: The image shows the Masimo logo and company information. The logo features a red circle with a white checkmark-like symbol inside, followed by the company name "Masimo" in bold, black font. To the right of the logo, the text "MASIMO CORP" is displayed in gray, along with the address "52 Discovery, Irvine, CA 92618".

5.5. Summary of Design Control Activities

The hardware and software was modified to add the wireless capabilities to EMMA. See summary of Design Control Activities provided below.

Modification	Test Performed	Test Results
Hardware and software wasmodified to add wirelessradio module	EMC Testing in accordance with IEC60601-1-2:2014, including radiatedimmunity to 10 V/m.	Testing supports theaddition of the wirelessradio capabilities does notimpact the essentialperformance.
	Radio co-existence testing in accordancewith the FDA Guidance for RadioFrequency Wireless Technology inMedical Devices	Testing supports thequality of the service ofthe wireless connection ismaintained under normaland anticipated abnormalconditions.
	Cybersecurity testing in accordance withthe FDA Guidance for Content ofPremarket Submissions for Managementof Cybersecurity in Medical Devices	Testing supports theacceptability of thecybersecurity risks.
Storage and TransportSpecification	Conducted operational verification afterstorage of the device at -40°C	Test supports theacceptability of the lowertemperature specification
Operating AtmosphericPressure	Conducted operational verification of thedevice at 60 kPa atmospheric pressure.	Test supports theacceptability of the lowertemperature specification.

Conclusion 5.6

The data supports the substantial equivalence of the subject device, EMMA with wireless capabilities, to the predicate.

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).