Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor

K172625 · Nonin Medical, Inc. · DQA · May 11, 2018 · Cardiovascular

Device Facts

• Record ID: K172625
• Device Name: Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: May 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Multi-Sensing Oximetry System when used with Model 8330AA sensor, is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms. • For %SpO2 and pulse rate, the multi-sense system is intended for use in professional healthcare facilities, mobile, and EMS settings in adult and pediatric patients (> 66 lbs/30 kg). • For %COHb, the multi-sense system is intended for use in professional healthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). This device should not be used to screen, diagnose or make treatment decisions related to suspected carbon monoxide poisoning.

Device Story

Multi-Sensing Oximetry System with Model 8330AA sensor uses noninvasive optical sensing to measure functional oxygen saturation (%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate. Device inputs are optical signals from finger clip sensor; signal processor transforms inputs into real-time data output. Used in professional healthcare, mobile, and EMS settings by trained personnel. Output displayed on monitor as numerical values and pleth waveform; assists clinicians in patient assessment alongside other clinical signs. Benefits include continuous or spot-check monitoring of physiological parameters. System includes Bluetooth, serial RS-232, and nurse call/analog output interfaces.

Clinical Evidence

Clinical testing conducted per ISO 80601-2-61 on healthy adult subjects (male/female, non-smoking, various skin tones). COHb accuracy measured over 0-15% range with 80-100% SaO2. SpO2 accuracy measured over 70-100% range with 0-15% COHb. Results demonstrated compliance with acceptance criteria and substantial equivalence to predicate.

Technological Characteristics

Reusable finger clip sensor; optical sensing principle. Powered by 7.2V Li-ion battery or 100-240 VAC adapter. Connectivity: Bluetooth, Serial RS-232, Nurse Call/Analog. Enclosure IP32. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, IEC 62304.

Indications for Use

Indicated for noninvasive measurement of %SpO2, %COHb, and pulse rate in adult and pediatric patients (> 66 lbs/30 kg). %SpO2 and pulse rate indicated for professional healthcare, mobile, and EMS settings. %COHb indicated for professional healthcare facilities. Contraindicated for screening, diagnosing, or making treatment decisions for suspected carbon monoxide poisoning.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Model X-100C System with Model 8300AA Sensor (K160231)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 11, 2018

Nonin Medical Inc. Kim Aves Principal Regulatory Affairs Specialist 13700 1st Avenue North Plymouth, Minnesota 55441

Re: K172625

Trade/Device Name: Multi-Sensing Oximetry System with Model 8330AA Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: April 3, 2018 Received: April 9, 2018

Dear Kim Aves:

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. 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); 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.

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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Tina Kiang
s

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

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## Indications for Use

510(k) Number (if known) K172625

Device Name

Multi-Sensing Oximetry System with Model 8330AA Sensor

#### Indications for Use (Describe)

The Multi-Sensing Oximetry System when used with Model 8330AA sensor, is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.

· For %SpO2 and pulse rate, the multi-sense system is intended for use in professional healthcare facilities, mobile, and EMS settings in adult and pediatric patients (> 66 lbs/30 kg).

· For %COHb, the multi-sense system is intended for use in professional healthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). This device should not be used to screen, diagnose or make treatment decisions related to suspected carbon monoxide poisoning.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 5. "510(k) Summary" as required by section 807.92(c)

| Submitter: | Nonin Medical, Inc.<br>13700 1st Ave. North<br>Plymouth, MN 55441-5443 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | 763 577 3196 |
| Fax: | 763 553 7807 |
| Contact Person: | Kim E. Aves<br>Principal Regulatory Affairs Specialist |
| Date Prepared: | 10 May, 2018 |
| Trade Names: | Multi-Sensing Oximetry System with Model 8330AA Sensor |
| Common Name: | Oximeter |
| Classification Name: | Oximeter |
| Regulation Number: | Class II, 21 CFR 870.2700 (Oximeter) |
| Product Code, Panel: | DQA, Anesthesiology |
| Predicate Device(s): | Model X-100C System with Model 8300AA Sensor (K160231) |
| | The Model 8300AA reusable finger clip sensor is intended for noninvasive<br>measuring of functional oxygen saturation of arterial hemoglobin<br>(%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate of<br>adult and pediatric patients (> 66 lbs / 30 kg). The measurements may be<br>multiple spot-checks to observe change and/or continuous monitoring. It<br>is intended for use in Emergency Medical Service (EMS), hospitals,<br>medical facilities, and mobile environments. This device is not meant for<br>sole use in clinical decision making; it must be used in conjunction with<br>additional methods of assessing clinical signs and symptoms. |
| Device Description: | Nonin Medical's Multi-Sensing Oximetry system, when used with Model<br>8330AA reusable finger clip sensor, is based on Nonin's SenSmart™<br>technology platform, displays (%COHb), pulse oxygen saturation (%SpO2),<br>and pulse rate (PR) data transmitted from one channel of data through a<br>direct connection of a signal processor to the monitor. The model<br>8330AA sensor provides real time data output of COHb, SpO2, and PR. |
| Intended Use: | Multi-Sensing Oximetry System with 8330AA Sensor |
| | The Multi-Sensing Oximetry System when used with Model 8330AA<br>sensor, is intended for noninvasive measuring of functional oxygen<br>saturation of arterial hemoglobin ( $%SpO2$ ), carboxyhemoglobin<br>saturation ( $%COHb$ ), and pulse rate. The measurements may be multiple<br>spot-checks to observe change and/or continuous monitoring. This<br>device is not meant for sole use in clinical decision making; it must be<br>used in conjunction with additional methods of assessing clinical signs<br>and symptoms. |
| | • For $%SpO2$ and pulse rate, the multi-sense system is intended for use<br>in professional healthcare facilities, mobile, and EMS settings in adult and<br>pediatric patients (> 66 lbs/30 kg). |
| | • For $%COHb$ , the multi-sense system is intended for use in professional<br>healthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). This<br>device should not be used to screen, diagnose or make treatment<br>decisions related to suspected carbon monoxide poisoning. |
| Testing: | The Nonin Model 8330AA sensor when used with Multi-Sensing<br>Oximetry System is supported by electrical safety testing,<br>electromagnetic compatibility, device performance, and clinical testing<br>to ensure appropriate functionality and to demonstrate substantial<br>equivalence to the predicate devices. |
| Functional Testing: | The results of the testing demonstrate equivalency with the predicate<br>devices and compliance to current recognized standards. Table 1<br>summarizes test results for the proposed devices, which met the relevant |

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| Table 1 | | |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Test | Reference | Results |
| Strain Relief Pull Strength | Internal | Pass |
| Operating Temp & Humidity | IEC 60601-1:2005 Sub-Clause 7.9.3.1,<br>EN1789:2007 Sub-clause 6.3.2<br>IEC 60601-1-11:2010 Sub-clause 4.2.2. | Pass |
| Thermal Shock | IEC 60601-1-11:2010 Sub-clause 4.2.3 | Pass |
| Drop & Swing<br>(Free Fall) | IEC 60601-1:2005 Sub-clauses 15.3.4.1 and 15.3.4.2<br>ISO 80601-2-61:2011 Sub-Clause 201.15.3.5.101.2<br>IEC 60601-1-11:2010 Sub-clause 10.1.3<br>IEC 60601-1-12:2014 Sub-clause 10.1.3<br>EN 1789:2007 Sub-clause 6.4.2 | Pass |
| ESU Interference | ANSI/AAMI EC 13:2002/(R) 2007 | Pass |
| Defib Proof | IEC 60601-1:2005 Clause 8.5.5 | Pass |
| Storage & Transport Tempo & Humidity | IEC 60601-1-11:2010 Sub-clause 4.2.1 & 4.2.2<br>IEC 60601-1-12 Sub-clause 4.2.1 & 4.2.2<br>IEC60601-1:2005/Al:2012 Sub-clause 7.9.3.1 | Pass |
| Dielectric Strength, Patient Leakage<br>Current, Pre-conditioning | IEC 60601-1:2005 Sub-clause 5.7, 6.3 8.7 & 8.8.3 | Pass |
| Excessive Temp | IEC 60601-1:2005 Sub-clause 11.1.2 | Pass |
| Hyperbaric Pressure | Internal | Pass |

requirements of the applicable recognized standards.

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| Sensor Image SW V&V | FDA 938:2002<br>IEC 62304:2008 | Pass |
|---------------------|-----------------------------------|------|
| CoHb Clinical Study | ISO 14155<br>ISO 80601-2-61 (REF) | Pass |
| SpO2 Clinical Study | ISO 14155<br>ISO 80601-2-61 (REF) | Pass |
| Pulse Rate Testing | ISO 80601-2-61 (REF) | Pass |

#### Accuracy (clinical) testing:

#### COHb Accuracy Testing

COHb accuracy testing was conducted at an independent research laboratory on healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older.

The measured carboxyhemoglobin value (%COHb) of the sensors was compared to simultaneous arterial blood samples as assessed by cooximetry. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the COHb range of 0-15% with 95 - 100% SaO2. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment-Particular requirements for basic safety and essential performance of pulse oximeter equipment.

#### COHb Accuracy Testing with Elevated HHb (Deoxyhemoglobin)

COHb accuracy testing was conducted at an independent research laboratory on healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older.

The measured carboxyhemoglobin value (%COHb) of the sensors was compared to simultaneous arterial blood samples as assessed by cooximetry. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the COHb range of 0-15% with 80 - 100% SaO2. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment-Particular requirements for basic safety and essential performance of pulse oximeter equipment.

#### SpO2 Accuracy Testing in Presence of COHb

During no-motion conditions at an independent research laboratory, SpO2 accuracy testing in the presence of COHb was conducted during induced hypoxia studies on healthy, male and female, non-smoking, lightto dark-skinned subjects that were 18 years of age and older.

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| The measured arterial hemoglobin saturation value (SpO₂) of the sensors |
|-------------------------------------------------------------------------|
| was compared to arterial hemoglobin oxygen (SaO₂) value, determined |
| from blood samples with a laboratory co-oximeter. |

The accuracy of the sensors in comparison to the co-oximeter samples was measured over the SpO₂ range of 70-100%, range 0-3% COHb and 80 – 100%, range 0 – 15% COHb. Testing was also conducted over the SpO₂ range of 70-100%.

Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment— Particular requirements for basic safety and essential performance of pulse oximeter equipment.

Testing conclusion: The proposed Model 8330AA Sensor meets all acceptance criteria. Based on test results, analysis and comparison to the legally marketed predicates, the Model 8330AA when used with Nonin Medical's Multi-Sensing Oximetry System is substantially equivalent to the predicate device for its intended use.

| Summary of<br>Substantial<br>Equivalence: | The Model 8330AA Sensor has the following similarities to the predicate devices:<br>• Similar indications for use - different wording, same indications<br>• Similar intended use environments<br>• Identical patient population<br>• Same primary mode of operation<br>• Performs equivalently to the similar specifications<br>A comparison table is on the following pages. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The proposed system is substantially equivalent to the predicate |

system.

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Page 5 of 8

# K172625 Comparison of Proposed Multi-Sensing Oximetry System with Model 8330AA Sensor to Predicate, Model X-100C CO-Met Oximetry System with Model 8300AA

| CATEGORY | Identical/<br>Similar/<br>Different | Model X-100C CO-Met Oximetry System<br>Multi-Sensing Oximetry System<br>With Model 8330AA Sensor (Proposed) | Model X-100C System<br>With Model 8300AA Sensor (Predicate) |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | | | |
| System | Similar – The<br>indications<br>are differently<br>worded for<br>clarification of<br>intended use<br>environments.<br>The subject<br>device also<br>does not have<br>MetHb<br>functionality. | The Multi-Sensing Oximetry System with the Model 8330AA<br>reusable finger clip sensor is intended for noninvasive measuring<br>of functional oxygen saturation of arterial hemoglobin (%SpO2),<br>carboxyhemoglobin saturation (%COHb), and pulse rate. The<br>measurements may be multiple spot-checks to observe change<br>and/or continuous monitoring. This device is not meant for sole<br>use in clinical decision making; it must be used in conjunction<br>with additional methods of assessing clinical signs and<br>symptoms.<br>• For %SpO2 and pulse rate, the 8330AA is intended for use in<br>professional healthcare facilities, mobile, and EMS settings in<br>adult and pediatric patients (> 66 lbs/30 kg).<br>• For %COHb, the 8330AA is intended for use in professional<br>healthcare facilities settings in adult and pediatric patients (> 66<br>lbs/30 kg). This device should not be used to screen, diagnose or<br>make treatment decisions related to suspected carbon monoxide<br>poisoning.<br><br>Rxonly CAUTION: Federal law (USA) restricts this device to sale<br>by or on the order of a licensed practitioner. | Nonin's X-100C System is indicated for noninvasive spot-<br>checking and/or continuous monitoring of<br>Carboxyhemoglobin (COHb), Methemoglobin (MetHb),<br>functional oxygen saturation of arterial hemoglobin (SpO2)<br>and pulse rate of adult and pediatric patients using the<br>8300AA sensor.<br>The X-100C System is indicated for use by trained personnel<br>in clinical and non-clinical settings, including Emergency<br>Medical Service (EMS), hospitals, medical facilities, mobile<br>environments, and home healthcare.<br><br>Rxonly CAUTION: Federal law (USA) restricts this device to<br>sale by or on the order of a licensed practitioner. |
| Oxygen Saturation<br>Range (%SpO2) | Identical | 0-100% | 0-100% |
| Carboxyhemoglobin<br>Saturation Range | Identical | 0-99% (%COHb) | 0-99% (%SpCO) |
| Methemoglobin<br>Saturation Range | Different –<br>Subject<br>devices does<br>not include<br>MetHb<br>measurement | N/A | 0-99.9% (%SpMet) |
| Pulse Rate Display<br>Range | Identical | 18-321 beats per minute (bpm) | 18-321 beats per minute (bpm) |
| K172625<br>Page 6 of 8 | | | |
| CATEGORY | Identical/<br>Similar/<br>Different | Multi-Sensing Oximetry System<br>With Model 8330AA Sensor (Proposed) | Model X-100C System<br>With Model 8300AA Sensor (Predicate) |
| Accuracy | | | |
| Oxygen Saturation<br>(%SpO₂) non-motion | Identical | Refer to Oxygen Saturation (SpO₂) with elevated<br>Carboxyhemoglobin and Oxygen Saturation (SpO₂) | Refer to Oxygen Saturation (SpO2) with elevated<br>Carboxyhemoglobin and Oxygen Saturation (SpO2) with<br>elevated Methemoglobin |
| Carboxyhemoglobin<br>Accuracy | Similar | Adults, Pediatrics<br>• ±3 Arms (COHb range of 0-15%, SaO₂ 95-100%)<br>• ±3 Arms (COHb range of 0-5%, SaO₂ 95-100%)<br>• ±2 Arms (COHb range of 5-10%, SaO₂ 95-100%)<br>• ±2 Arms (COHb range of 10-15%, SaO₂ 95-100%) | Adults, Pediatrics<br>• ±2 Arms (COHb range of 0-15%, SaO₂ 95-100%)<br>• ±3 Arms (COHb range of 0-5%, SaO₂ 95-100%)<br>• ±2 Arms (COHb range of 5-10%, SaO₂ 95-100%)<br>• ±2 Arms (COHb range of 10-15%, SaO₂ 95-100%) |
| Carboxyhemoglobin<br>Accuracy with<br>elevated HHb | Similar | Adults, Pediatrics<br>• ±3 Arms (COHb range of 0-15%, SaO₂ 80-100%)<br>• ±3 Arms (COHb range of 0-5%, SaO₂ 80-100%)<br>• ±2 Arms (COHb range of 5-10%, SaO₂ 80-100%)<br>• ±3 Arms (COHb range of 10-15%, SaO₂ 80-100%) | Adults, Pediatrics<br>• ±3 Arms (COHb range of 0-15%, SaO₂ 80-100%)<br>• ±3 Arms (COHb range of 0-5%, SaO₂ 80-100%)<br>• ±2 Arms (COHb range of 5-10%, SaO₂ 80-100%)<br>• ±3 Arms (COHb range of 10-15%, SaO₂ 80-100%) |
| Oxygen Saturation<br>(SpO₂) with elevated<br>Carboxyhemoglobin | Similar | Adults, Pediatrics<br>• ±2 Arms (COHb range of 0-3%, SaO₂ 70-100%)<br>• ±3 Arms (COHb range of 0-3%, SaO₂ 70-80%)<br>• ±2 Arms (COHb range of 0-3%, SaO₂ 80-90%)<br>• ±2 Arms (COHb range of 0-3%, SaO₂ 90-100%) | Adults, Pediatrics<br>• ±2 Arms (COHb range of 0-3%, SaO₂ 70-100%)<br>• ±2 Arms (COHb range of 0-3%, SaO₂ 70-80%)<br>• ±3 Arms (COHb range of 0-3%, SaO₂ 80-90%)<br>• ±2 Arms (COHb range of 0-3%, SaO₂ 90-100%) |
| Pulse Rate Accuracy | | | |
| Pulse Rate Accuracy<br>non-motion | Identical | Adults, Pediatrics: ±3 digits (40-250 bpm) | Adults, Pediatrics: ±3 digits (40-250 bpm) |
| Electrical | | | |
| Standalone<br>• AC Power<br>Requirements<br>• Power<br>consumption<br>• Fuses | Identical | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz |
| Batteries<br>• Type<br>• Capacity<br>• Charging Time | Identical | 7.2 volt Li-ion battery pack, 2.4 Ah when charged<br>6 hours¹<br>2.5 hours | 7.2 volt Li-ion battery pack, 2.4 Ah when charged<br>6 hours¹<br>2.5 hours |
| K172625<br>Page 7 of 8 | | | |
| CATEGORY | Identical/<br>Similar/<br>Different | Multi-Sensing Oximetry System<br>With Model 8330AA Sensor (Proposed) | Model X-100C System<br>With Model 8300AA Sensor (Predicate) |
| Environmental | | | |
| Operating<br>Temperature | Identical | 32 °F to 104 °F (0 °C to 40 °C) | 32 °F to 104 °F (0 °C to 40 °C) |
| Storage/Transport<br>Temperature | Identical | -22 °F to 158 °F (-30 °C to 70 °C) | -22 °F to 158 °F (-30 °C to 70 °C) |
| Operating Humidity | Identical…