(212 days)
Not Found
No
The description details a standard infrared thermometer using a thermopile sensor and thermistor, with no mention of AI, ML, or complex algorithms beyond basic temperature conversion and storage.
No.
This device is an infrared thermometer, intended for measuring human body temperature. It performs a diagnostic function (measurement) but does not provide therapy or treatment.
Yes
The device is used to measure human body temperature, which is a physiological parameter. While the document states it's for "reference" for doctors, measuring body temperature is a common diagnostic aid for various medical conditions (e.g., fever indicating infection). Therefore, it serves a diagnostic purpose by providing data relevant to a patient's health status.
No
The device description explicitly states it is a hand-held, battery-powered device composed of a measuring sensor, PCB, buttons, LCD, and enclosure, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: This device measures human body temperature by detecting infrared heat emitted from the forehead. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is for measuring body temperature, which is a physiological measurement, not an in vitro diagnostic test.
Therefore, based on the provided information, this infrared thermometer is a medical device, but it falls under a different classification than an IVD.
N/A
Intended Use / Indications for Use
Infrared Thermometer (model: CK-T1501, CK-T1502, CK-T1503) is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Infrared Thermometer (model: CK-T1501,CK-T1502,CK-T1503) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when meas ure from 3-5 cm of the subiect's forehead with no contact.
It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.
It composed by a measuring sensor, PCB, 4 buttons, a LCD and an enclosure. The functions of the three models are similar. The functions of "Temperature Alarm Point", "Temperature Offset", and "Warning Tone Switch" can be set. When measuring body temperature, users need to measure in body mode from 3-5 cm from their forehead. Press the measuring key, after 0.5 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 15 sec. The No. and stored value of the stored data are displayed at the bottom of the LCD screen. Press "+" / " -" to view the previous or next stored data, it can store 32 sets of measurements.
User contact components are the enclosure and keys. The materials of the components are ABS plastic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
People over one month old
Intended User / Care Setting
consumers in homecare environment and doctors in clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2009). The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
The clinical tests evaluated 240 of subjects. and the thermometer was evaluated in three age groups including subgroup A1 and A2: A1 – one month up to three month, A2 - three months to one year; B - older than one years and younger than five years; and C - older than five years old. The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56 and ASTM E1965-98 (2016). The test report showed the clinical performance of the subject devices complied with the requirement of ISO 80601-2-56 and ASTM E1965-98 (2016).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was conducted to verify that the subject devicesmet all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:
A. Electromagnetic Compatibility, Electrical Safety, and Battery Safety:
The subject devices were tested in compliance with the following:
- ANSI/AAMIES60601-1 Medicalelectricalequipment-Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- ISO 80601-2-56 First Edition 2009-10-01, Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
B. Biocompatibility: - Patient contactingcomponents were subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10).
C. Software Verification: Software documentation was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
D. Performance Testing: - ISO 80601-2-56 First Edition 2009-10-01, Medicalelectrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinicalthermometers for body temperature measurement
- ASTME1965-98 (2016): Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2009). The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
The clinical tests evaluated 240 of subjects. and the thermometer was evaluated in three age groups including subgroup A1 and A2: A1 – one month up to three month, A2 - three months to one year; B - older than one years and younger than five years; and C - older than five years old. The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56 and ASTM E1965-98 (2016). The test report showed the clinical performance of the subject devices complied with the requirement of ISO 80601-2-56 and ASTM E1965-98 (2016).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.
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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 17, 2020
Shenzhen Changkun Technology Co., Ltd. % Cassie Lee Official Correspondent Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, 510000 China
Re: K193253
Trade/Device Name: Infrared Thermometer, Models: CK-T1501, CK-T1502, CK-T1503 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 23, 2020 Received: May 18, 2020
Dear Ms. Cassie Lee:
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/cdrl/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.
1
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) 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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.
for Tina Kiang, Ph.D. Director 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) K193253
Device Name
Infrared Thermometer (Models: CK-T1501, CK-T1502, CK-T1503)
Indications for Use (Describe)
Infrared Thermometer (model: CK-T1501, CK-T1503) is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
| 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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3
510(k) Summary
K193253
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary prepared: 2020-05-25
2. Submitter'sInformation
510(k) Owner's Name: Shenzhen Changkun Technology Co., Ltd. Establishment Registration Number : Applying Address: 801, 3 floor 4floor 6floor 7floor, B building, NO.69, zhenbi road, biling community, biling street, pingshan district, Shenzhen city, Guangdong, China Tel: +0755-29100487 Fax: +0755-29100487 Contact Person: Steve Li Email: changkunkj@163.com
Application Correspondent:
Contact Person: Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory @glomed-info.com
3. Subject Device Information
Trade Name: Infrared Thermometer, models: CK-T1501, CK-T1502, CK-T1503 Common Name: Clinical electronic thermometer Classification name: Thermometer, electronic, clinical Review Panel: General Hospital Product Code: FLL Regulation Class: II Regulation Number: 21 CFR 880.2910
4. Predicate Device Information
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| Sponsor: | Shenzhen Changkun Technology Co., Ltd. |
|---|---|
| Subject Device: | Infrared Thermometer, Models: CK-T1501, CK-T1502, CK-T1503 |
Sponsor: Intrinity Global Limited Trade Name: Non Contact Infrared Forehead Thermometer(model : TVT-200, TVT-200 PLUS) Common Name: Clinical electronic thermometer Classification Name: Thermometer, Electronic, Clinical 510(K) Number: K170662 Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulation Class: II
5. Device Description
Infrared Thermometer (model: CK-T1501,CK-T1502,CK-T1503) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when meas ure from 3-5 cm of the subiect's forehead with no contact.
lt uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.
It composed by a measuring sensor, PCB, 4 buttons, a LCD and an enclosure. The functions of the three models are similar. The functions of "Temperature Alarm Point", "Temperature Offset", and "Warning Tone Switch" can be set. When measuring body temperature, users need to measure in body mode from 3-5 cm from their forehead. Press the measuring key, after 0.5 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 15 sec. The No. and stored value of the stored data are displayed at the bottom of the LCD screen. Press "+" / " -" to view the previous or next stored data, it can store 32 sets of measurements.
User contact components are the enclosure and keys. The materials of the components are ABS plastic.
6. Intended Use / Indications for Use
Infrared Thermometer (model: CK-T1501, CK-T1502, CK-T1503) is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Infrared Thermometer is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of
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safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | Shenzhen Changkun | ||
| Technology Co., Ltd. | Intrinity Global Limited | -- | |
| Trade Name | Infrared Thermometer | Non Contact Infrared Forehead | |
| Thermometer | -- | ||
| Classification | |||
| Name | Clinical Electronic Thermometer | Clinical Electronic Thermometer | Same |
| 510(k) | |||
| Number | K193253 | K170662 | -- |
| Product Code | FLL | FLL | Same |
| Thermometer | |||
| Type | Infrared Forehead Thermometer | Infrared Forehead Thermometer | Same |
| Intended Use | |||
| / Indications | |||
| for Use | Infrared Thermometer (model: | ||
| CK-T1501, CK-T1502, | |||
| CK-T1503) is a non-sterile, | |||
| reusable, non-contact and | |||
| handheld device. It can be used | |||
| by consumers in homecare | |||
| environment and doctors in clinic | |||
| as reference. It is intended for | |||
| measuring human body | |||
| temperature of people over one | |||
| month old by detecting infrared | |||
| heat from the forehead. | Non Contact Infrared Forehead | ||
| Thermometer is a non-sterile, | |||
| reusable, handheld device. It | |||
| can be used by consumers in | |||
| homecare environment and | |||
| doctors in clinic as reference. It | |||
| is intended for measuring | |||
| human body temperature of all | |||
| ranges of people by detecting | |||
| infrared heat from the forehead. | Similar | ||
| Note 3 | |||
| Display | LCD Digital Display | LCD Digital Display | Same |
| Measurement | |||
| method | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement | |||
| mode | Forehead measure mode | Forehead measure mode | Same |
| Measuring | |||
| range | 32°C | 32°C to 43°C (89.6°Fto109.4°F) | Similar |
| Note 1 | |||
| Display | |||
| resolution | 0.1°C/0.1°F | 0.1°C/0.1°F | Same |
| C/F | |||
| switchable | YES | YES | Same |
| Measuring | 32°C~34.9°C ±0.3°C/ | +0.2°C (0.4°F) | Similar |
| Elements of | Subject Device | Predicate Device | Verdict |
| Comparison | |||
| accuracy | 89.6 °F~94.8°F ±0.5°F | ||
| 35°C~42°C ±0.2°C/ | |||
| 95.0°F~107.6°F±0.4°F | |||
| 42.1°C~42.5°C ±0.3°C/ | |||
| 107.8°F~108.5°F ±0.5°F | Note 1 | ||
| Measurement | |||
| distance | 3-5cm | 1cm | Similar |
| Note 1 | |||
| Display | LCD | LCD | Same |
| Memory | 32 sets. | 16 sets. | Similar |
| Note 2 | |||
| Power source | DC 3V | ||
| (2 of AA alkaline | |||
| batteries) | DC 3V | ||
| (2 of AA alkaline | |||
| batteries ) | Same | ||
| Operating | |||
| condition | 10°C ~ 40°C; | ||
| 15% ~ 85%RH; | |||
| 80kPa~106kPa | 15°C | ||
| ≤95% RH | Similar | ||
| Note 2 | |||
| Patient | |||
| contact | |||
| materials | ABS | ABS with colorants (pink, grey, | |
| orange and purple), Glass and | |||
| Metal | Same | ||
| Electric | |||
| Safety | |||
| and EMC | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-1-11 | |||
| ISO 80601-2-56 | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-1-11 | |||
| ISO 80601-2-56 | Same |
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Sponsor: Shenzhen Changkun Technology Co., Ltd. Infrared Thermometer, Models: CK-T1501, CK-T1502, CK-T1503 Subject Device:
Comparison in Detail(s):
Note 1:
The "measuring range", "Measurement distance" and "Measuring accuracy" of the subject device is similar with predicate device, both of them meet the requirement of safety and essential performance standard ISO 80601-2-56. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 2:
The "Memory" and "Operating condition" of subject device is similar with predicate device, the software verification and validation test met the requirements. The performance testing shows that the subject device complies with performance standard.
The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
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Note 3:
Although the "Intended Use / Indications for Use" of subject device is a little different from the predicate devices, but both of subject device and predicate device are meet the clinical accuracy requirements of the standards ISO 80601-2-56 and ASTM E1965-98. Based on the performance evaluation, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
8. Summary of Non-Clinical Testing
8.1 Non-clinical testing was conducted to verify that the subject devicesmet all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed: A. Electromagnetic Compatibility, Electrical Safety, and Battery Safety:
The subject devices were tested in compliance with the following:
- � ANSI/AAMIES60601-1 Medicalelectricalequipment-Part 1: General requirements for basic safety and essential performance
- � IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- � IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- � ISO 80601-2-56 First Edition 2009-10-01, Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
B. Biocompatibility:
- � Patient contactingcomponents were subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within
8
a risk management process, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10).
C. Software Verification: Software documentation was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
D. Performance Testing:
- ◆ ISO 80601-2-56 First Edition 2009-10-01, Medicalelectrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinicalthermometers for body temperature measurement
- ◆ ASTME1965-98 (2016): Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
8.2 Discussion of Clinical TestsPerformed
The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2009). The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
The clinical tests evaluated 240 of subjects. and the thermometer was evaluated in three age groups including subgroup A1 and A2: A1 – one month up to three month, A2 - three months to one year; B - older than one years and younger than five years; and C - older than five years old. The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56 and ASTM E1965-98 (2016). The test report showed the clinical performance of the subject devices complied with the requirement of ISO 80601-2-56 and ASTM E1965-98 (2016).
9. Conclusion:
Based on the performance testing, comparison and analysis in this submission, the subject device Infrared Thermometer (model: CK-T1501, CK-T1502, CK-T1503) is substantially equivalent to the predicate device K 170662.