Infrared Ear Thermometer
Infrared Ear Thermometer HTD8208C measures body temperature from the auditory canal using a thermopile sensor. It detects infrared radiation from eardrum tissue and converts the signal into…
Infrared Ear Thermometer HTD8208C measures body temperature from the auditory canal using a thermopile sensor. It detects infrared radiation from eardrum tissue and converts the signal into a temperature shown on an LCD.
The handheld device is intended for home use in people of all ages. A measurement button starts acquisition, and the measurement process takes less than five seconds.
Display Features
The thermometer can display Celsius or Fahrenheit values and includes a high-temperature warning and low-battery indicator. Its stated measurement range is 34.0 to 42.9 degrees Celsius. The case and patient-contact components use ABS plastic.
Who Else Makes It
Concentrated in Guangdong (68), Zhejiang (15), Jiangsu (13). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 36 |
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Famidoc Technology Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 9 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 6 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
Showing 12 of 115. All 115 manufacturers in China registered for Continuous Measurement Thermometer
Record
| Listed by | Hetaida Technology Co., Ltd., China |
|---|---|
| FDA product code | FLL |
| Device type | Continuous Measurement Thermometer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2910 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K180387 |
| Record published | 2019-03-28 |
| Record revised | 2026-05-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 55 °C; Storage environment humidity 0 to 93 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 15 to 35 °C; Handling environment humidity 0 to 93 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Pack of 40 |
| Sizes | Height 45 mm; width 36 mm; length 160 mm |
| Distribution end date | 2026-05-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HTD8208C | Height 45 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 434 |
| Safety 1st | Dorel Juvenile Group, Inc. | 180 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Diagnostix™ | American Diagnostic Corp. | 61 |
| DeRoyal | Deroyal Industries, Inc. | 58 |
| Braun | KAZ USA, Inc. | 53 |
| Exergen Temporal Scanner | Exergen Corporation | 50 |
| Level 1 | ICU Medical, Inc | 48 |
| Famidoc | Famidoc Technology Co., Ltd. | 47 |
| Adtemp™ | American Diagnostic Corp. | 35 |
| TempTraq | Blue Spark Technologies, Inc. | 35 |
| Medline | Medline Industries, Inc. | 34 |
Showing 12 of 843. All products under Continuous Measurement Thermometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203332 | 2021-02-25 |
| K200159 | 2021-01-05 |
| K180387 | 2019-01-10 |
| K171888 | 2018-07-23 |
| K180385 | 2018-05-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.