Infrared Body Thermometer

K200781 · Heitaida Technology Co., Ltd. · FLL · Dec 9, 2020 · General Hospital

Device Facts

• Record ID: K200781
• Device Name: Infrared Body Thermometer
• Applicant: Heitaida Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Dec 9, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Infrared Body Thermometer, Model: HTD822US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and auditory canal in people of all ages for home setting use.

Device Story

Hand-held, battery-powered infrared thermometer; measures body temperature via forehead (non-contact) or auditory canal (contact). Input: infrared energy emitted from forehead or tympanic membrane/surrounding tissues; focused via parabolic mirror onto thermopile sensor. Integrated thermistor provides ambient temperature compensation. User operates device by pressing On/Scan button; device performs signal amplification and calculation; result displayed on LCD. Used in home settings by patients or caregivers. Provides temperature readings to assist in clinical decision-making regarding fever management.

Clinical Evidence

Clinical accuracy testing conducted per ASTM E1965-98 (2016) on 140 subjects across three age groups (0-1 year, 1-5 years, >5 years). Results demonstrated clinical bias and repeatability within acceptable limits for forehead, forehead scan, and ear modes, confirming compliance with ASTM standards.

Technological Characteristics

Hand-held infrared thermometer; thermopile sensor with integrated thermistor; parabolic mirror for energy focusing. Materials: ABS757 (shell/button), PMMA (LCD). Power: DC3.0V (CR2032). Connectivity: None. Standards: ANSI AAMI ES60601-1, IEC 60601-1-11, IEC 60601-1-2, ASTM E1965-98, ISO 80601-2-56, ISO 10993-5/10.

Indications for Use

Indicated for intermittent determination of body temperature from forehead and auditory canal in people of all ages in home settings.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

• Braun No Touch + Forehead NTF3000 Thermometer (K163516)
• TemporalScanner Thermometer (K011291)
• Braun Thermoscan® PRO 6000 Ear Thermometer (K152748)

Submission Summary (Full Text)

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December 9, 2020

HeiTaiDa Technology Co., Ltd. % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd RM. 1711, Building K. NO. 101 Science Ave International Creative Vallev Guangzhou, 510663 Cn

Re: K200781

Trade/Device Name: Infrared Body Thermometer, Model: HTD8222US Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 9, 2020 Received: November 9, 2020

Dear You Yijie:

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.

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

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

Sincerely,

CAPT Alan Stevens Director (acting) DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200781

Device Name Infrared Body Thermometer, Model: HTD8222US

Indications for Use (Describe)

The Infrared Body Thermometer, Model: HTD822US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and auditory canal in people of all ages for home setting use.

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) Summary

## 1. Submitter's Information

### Establishment Reqistration Information

Name: HeTaiDa Technology Co., Ltd Address: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China. 523820

## Contact Person of applicant

Name: Tom Chen Address: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China TEL: [phone] FAX: [phone] Email: [e-mail]

## Contact Person of the Submission:

Name: Yijie You Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: [phone] FAX: [phone] Email: [e-mail]

Date prepared: December 8, 2020

## 2. Device Information

| Type of 510(k) submission: | Traditional |
|----------------------------|-----------------------------------|
| Device Common Name: | Clinical electronic thermometer |
| Trade Name: | Infrared Body Thermometer |
| Model: | HTD8222US |
| Regulation name: | thermometer, electronic, clinical |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Class: | II |
| Regulation Number: | 880.2910 |
| 510(K) number: | K200781 |

## 3. Predicate Device Information

#### Predicate Device #1:

510(k) submitter/holder: KAZ USA, Inc., A Helen of Troy Company 510(K) Number: K163516 Model: Braun No Touch + Forehead NTF3000 Thermometer

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Trade name: Infrared Thermometer Review Panel: General Hospital Product Code: FLL Requlation Class: II Requlation Number: 880.2910

## Predicate Device #2:

510(k) submitter/holder: Exergen Corporation 510(K) Number: K011291 TemporalScannerThermometer Trade name: Review Panel: General Hospital Product Code: FLL Regulation Class: II Regulation Number: 880.2910

## Predicate Device #3:

510(k) submitter/holder: KAZ USA, Inc (a Subsidiary of Helen of Troy, Inc) K152748 510(K) Number: Trade name: Braun Thermoscan® PRO 6000 Ear Thermometer Review Panel: General Hospital Product Code: FLL Regulation Class: II Regulation Number: 880.2910

## 4. Device description

Infrared Body Thermometer, model: HTD8222US, is a hand-held, battery powered, infrared thermometer that measures human body temperature through the opening of the auditory canal or on forehead, by measuring the infrared energy emitted in the area around the user's forehead or tympanic membrane and adjacent surfaces when placed within 1~5 centimeter of the subject's forehead or insert into auditory canal. The Infrared Body Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead or tympanic membrane and the adjacent surfaces for detection of non-contact use and contact use and compensation of the temperature reading.

The Infrared Body Thermometers measure temperature by pressing the On/Scan button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.

The device can measure temperature with three modes, forehead scan mode and ear mode.

Both forehead mode and forehead scan mode modes are non-contact with human body and measure forehead temperature. The forehead mode measures temperature from middle of the forehead, forehead scan mode measures temperature by scan the forehead from left to right or from right to left with position light spot following within approximately 3~10 seconds, then the maximum temperature will display on the screen.

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The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. After removing the probe covering cap, the small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues emit IR radiation.

## Principle of operation:

Infrared Body Thermometer, model: HTD8222US, is a hand-held, battery powered, infrared thermometer that measures human body temperature through the opening of the auditory canal or on forehead, by measuring the infrared energy emitted in the area around the user's forehead or tympanic membrane and adjacent surfaces when placed within 1~5 centimeter of the subject's forehead or insert into auditory canal. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display.

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# 5. Indications for Use

The Infrared Body Thermometer, Model: HTD822US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and auditory canal in people of all ages for home setting use.

# 6. Comparison of technological characteristics with the predicate devices (K163516, K011291 and K152748)

| SE<br>Comparisons | Subject device<br>K200781<br>(Infrared Body<br>Thermometer,<br>model:<br>HTD8222US) | Predicate device #1<br>(K163516, Infrared<br>Thermometer, Model:<br>Braun No Touch +<br>Forehead NTF3000<br>Thermometer)<br>(compared with<br>Forehead mode of<br>HTD8222US) | Predicate device #2<br>(K011291,<br>TemporalScanner<br>Thermometer)<br>(compared with<br>Forehead scan mode<br>of HTD8222US) | Predicate device #3<br>(K152748, Braun<br>Thermoscan® PRO<br>6000 Ear<br>Thermometer)<br>(compared with ear<br>mode of<br>HTD8222US) | Discussion of<br>difference |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21CFR 880.2910 | 21CFR 880.2910 | 21CFR 880.2910 | 21CFR 880.2910 | Same |
| Product<br>Code | FLL | FLL | FLL | FLL | Same |
| FDA Class | II | II | II | II | Same |
| Indications<br>for Use | The Infrared Body<br>Thermometer, Model:<br>HTD8222US, is an<br>electronic clinical<br>thermometer using an<br>infrared sensor for the<br>intermittent<br>determination of body<br>temperature from the<br>forehead and auditory<br>canal in people of all<br>ages for home setting<br>use. | The Braun No Touch +<br>Forehead NTF3000<br>Thermometer is a<br>non-sterile, reusable<br>clinical thermometer<br>intended for the<br>Intermittent determination<br>of human body<br>temperature in a touch<br>and no touch mode on the<br>center of the forehead as<br>the measurement site on<br>people of all ages. | The TemporalScanner<br>Thermometer is an<br>infrared thermometer<br>intended for the<br>intermittent<br>measurement of human<br>body temperature of<br>people of all ages. | A non-sterile,<br>re-useable clinical<br>thermometer intended<br>for the intermittent<br>determination of the<br>human's body<br>temperature for<br>people of all ages | Same |
| Principle of<br>operation | Measure temperature<br>by reading infrared | Measure temperature by<br>reading infrared radiation | Measure temperature<br>by reading infrared | Measure temperature<br>by reading infrared | Same |
| | radiation emitting from the forehead tissue or tympanic membrane and adjacent surfaces when the thermometer is placed within few centimeters of forehead or inserted into auditory canal. | emitting from the forehead tissue when the thermometer is placed within few centimeters of forehead. | radiation emitting from the forehead tissue when the thermometer is placed within few centimeters of forehead. | radiation emitting from tympanic membrane and adjacent surfaces when the thermometer is inserted into auditory canal. | |
| target<br>population | people of all ages | people of all ages | people of all ages | people of all ages | Same |
| Measurement<br>site 1 | Forehead | forehead | forehead | NA | Same<br>Predicate 3 has no forehead mode, the subject device is compared with predicated devices 1 and 2 for this technical item, and shows same with predicated devices 1 and 2. Since modes work not at the same time, The difference will not affect the determination of substantial equivalence |
| Measurement<br>site 2 | ear | NA | NA | ear | Same<br>Predicate 1 and 2 has no ear mode, the proposed device is compared with predicated device 3 for this technical item, and shows same with predicated device 3. Since modes work not at the same time, the difference will not affect the determination of substantial equivalence |
| | | | | | |
| Type of thermometer | intermittent | intermittent | intermittent | intermittent | Same<br>All three predicate device<br>declare they are<br>intended for intermittent<br>measurement of human<br>body temperature which<br>is indicated in the<br>intended use/ Indications<br>for Use of 510(K)<br>summary. |
| Material of<br>Patient<br>contact<br>components | ABS | NA, not contact with<br>Patient body | ABS | Common Materials-<br>including an impact<br>resistant casing.<br>Biocompatible metals<br>and resins. | Similar<br>The proposed device has<br>been validated for<br>cytotoxicity per<br>ISO 10993- 5 and<br>Irritation as well as<br>Sensitization per ISO<br>10993-10. The difference<br>will not affect the<br>determination of substantial<br>equivalence |
| Biocompability | Nature of body contact<br>category: Surface<br>Contact class: A (<24 h)<br>User and patient<br>contacting material<br>Button:ABS757 (green)<br>LCD screen: PMMA<br>(transparent)<br>Shell: ABS757 (white)<br>Meets ISO 10993-5 and<br>ISO 10993-10 | Nature of body contact<br>category: Surface<br>Contact class: A (<24 h)<br>User contacting material<br>housing / handle<br>and power button: ABS<br>temperature button<br>and nose/forehead<br>touch bumper: TPR<br>Meets ISO 10993 | Nature of body contact<br>category: Surface<br>Contact class: A (<24 h)<br>User and patient<br>contacting material<br>ABS<br>Not public | Nature of body contact<br>category: Surface<br>Contact class: A (<24 h)<br>User and patient<br>contacting material<br>Common Materials-<br>including an impact<br>resistant casing.<br>Biocompatible metals<br>and resins.<br>Meets ISO 10993-5 and<br>ISO 10993-10 | Similar<br>Since the proposed device<br>has been Validated for<br>cytotoxicity per<br>ISO 10993- 5 and<br>Irritation as well as<br>Sensitization per ISO<br>10993-10, The difference<br>will not affect the<br>determination of substantial<br>equivalence |
| Environment | home | home | home | home | Same |
| Design | Handheld | Handheld | Handheld | Handheld | Same |
| Measurement<br>method | Infrared radiation<br>detection | Infrared radiation<br>detection | Infrared radiation<br>detection | Infrared radiation<br>detection | Same |
| Display Type | LCD | LCD | LCD | LCD | Same |
| Measurement<br>mode | Forehead mode/<br>Forehead scan mode/<br>ear mode | No touch way | Forehead scan | ear mode | Same |
| Key | One button(ON/Scan<br>button) | Two buttons(Power<br>button, Temperature<br>button) | One button<br>(SCAN Button) | Four buttons<br>(Measure button<br>C/F button<br>Memory button<br>Timer button) | Similar<br>The different button number<br>will not affect the<br>determination of substantial<br>equivalence |
| Scale<br>selection | °C/°F | °C/°F | °C/°F | °C/°F | Same |
| Display unit | °C/°F | °C/°F | °C/°F | °C/°F | Same |
| High<br>temperature<br>warning | Yes | Yes | Yes | No | Similar<br>The existed difference will<br>not affect the determination<br>of substantial equivalence |
| Low battery<br>indicator | Yes | Yes | Yes | Yes | Same |
| User<br>contacting<br>material | Button:ABS757 (green)<br>LCD screen: PMMA<br>(transparent)<br>Shell: ABS757 (white) | housing / handle<br>and power button: ABS<br>temperature button<br>and nose/forehead<br>touch bumper: TPR | ABS | Common Materials-<br>including an impact<br>resistant casing.<br>Biocompatible<br>metals and resins. | Similar<br>Since the proposed device has<br>been Validated for<br>cytotoxicity per<br>ISO 10993- 5 and<br>Irritation as well as<br>Sensitization per ISO<br>10993-10, The difference will<br>not affect the determination of<br>substantial equivalence |
| Sensor Type | Thermopile | Thermopile | Thermopile | Thermopile | Same |
| Performance | Meets ASTM E1965 | Meets ASTM E1965-98 | Meets ASTM E1965-98 | Meets ASTM<br>E1965-98 | Same |
| Electrical<br>Safety | ANSI AAMI<br>ES60601-1 | ANSI AAMI<br>ES60601-1 | ANSI AAMI<br>ES60601-1 | ANSI AAMI<br>ES60601-1 | Same |
| EMC Meets | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Measuring<br>Range<br>(forehead mode) | 34.0°C ~ 43.0°C | 34.4°C ~ 42.2°C | NA | NA | Similar<br>The proposed device meets<br>ASTM E1965-98, ISO |
| | | | | | 80601-2-56 and the<br>difference does not affect the<br>determination of substantial<br>equivalence. |
| | | | | | Similar<br>The proposed device meets<br>ASTM E1965-98, ISO<br>80601-2-56 and the<br>difference does not affect the<br>determination of substantial equivalence. |
| Measuring<br>Range<br>(forehead scan<br>mode) | $34.0°C ~ 43.0°C$ | NA | $15.5$ to $42°C$ | NA | |
| Measuring<br>Range<br>(ear mode) | $34.0°C ~ 43.0°C$ | NA | NA | $20.0$ to $42.2°C$<br>(68 to 108°F) | Similar<br>The proposed device meets<br>ASTM E1965-98, ISO<br>80601-2-56 and the<br>difference does not affect the<br>determination of substantial equivalence. |
| Display<br>resolution | $0.1°F (0.1°C)$ | $0.1°F (0.1°C)$ | $0.1°F (0.1°C)$ | $0.1°F (0.1°C)$ | Same |
| Measuring<br>accuracy | $±0.2°C (0.4°F)$ within<br>$35~42°C (95~107.6°F)$ ,<br>$±0.3°C (0.5°F)$ for<br>$34.0°C ~ 34.9°C$ and<br>$42.1°C ~ 43.0°C$ | $±0.2°C (0.4°F)$ within<br>$35~42°C (95~107.6°F)$ ,<br>$±0.3°C (0.5°F)$ for<br>$34.4°C ~ 34.9°C$ and<br>$42.1°C ~ 42.2°C$ | $±0.2°C (0.4°F)$ within<br>$35~42°C (95~107.6°F)$ ,<br>$±0.3°C (0.5°F)$ for<br>$34.0°C ~ 34.9°C$ and<br>$42.1°C ~ 43.0°C$ | $±0.2°C (0.4°F)$ within<br>$35~42°C (95~107.6°F)$ ,<br>$±0.3°C (0.5°F)$ for<br>$20.0°C ~ 34.9°C$ and<br>$42.1°C ~ 42.2°C$ | Same |
| Measure<br>time | ≤2S for Forehead<br>mode;<br>3~10s for Forehead<br>scan mode;<br>≤5s for ear mode. | ≤2S | Seconds | 2~3 Seconds | Similar<br>The Measure time will not<br>affect the determination of<br>substantial equivalence |
| Color<br>Indication | Green: ≥ $35.8°C$ -<br>$37.4 °C$<br>( $96.2°-99.4°F$ )<br>Yellow: ≥ $37.5°C$ -<br>$38.5°C$ ( $99.5°F$ -<br>$101.3°F$ ) | Green: > $35.7°-37.4 °C$<br>(> $96.3°$ - $99.4 °F$ )<br>Yellow: > $37.4°$ -<br>$38.5 °C$<br>(> $99.4°$ - $101.3 °F$ ) | NA | NA | Similar<br>The Color<br>Indication will not affect the<br>determination of substantial<br>equivalence |
| | | | | | |
| | Orange: ≥ 38.6 -<br>43.0°C (101.4 -<br>109.4°F) | Red: > 38.5° - 42.2 °C<br>(> 101.3° - 108.0 °F) | | | |
| Measuring<br>Distance | 1 CM -5CM | 1 CM -5CM | 0 CM | 0 CM | Similar |
| Power<br>source | DC3.0V X1<br>(CR2032) | Two (2) AA batteries | 9 volt Alkaline | Two AA Alkaline<br>Batteries | Similar |
| Expected<br>battery life | More than 1000<br>measurements | at least 1000<br>measurements | Approximately 7,500<br>readings | 1000 measurements | Similar |
| Clinical<br>accuracy<br>(forehead mode) | Clinical bias:<br>0.14°C/0.15°C/0.15°C<br><br>with Uncertainty:<br>$\pm$ 0.14/ $\pm$ 0.15/ $\pm$ 0.14<br>for group I/II/II<br><br>Clinical repeatability: | Not public | NA | NA | Different |
| | 0.12 °C<br>(Calculated per ASTM<br>E:1965-98) | | | | of proposed device are<br>sufficiently small and<br>acceptable which will not<br>affect the determination of<br>substantial equivalence<br>even though any difference<br>existed. |
| Clinical<br>accuracy<br>(forehead scan<br>mode) | Clinical bias:<br>0.16°C/0.15°C/0.14°C<br><br>with Uncertainty:<br>±0.10/ ±0.09/ ±0.09<br>for group I/II/II<br><br>Clinical repeatability:<br>0.12 °C<br>(Calculated per ASTM<br>E:1965-98) | NA…