Clinical Electronic Thermometer
General Hospital · 21 CFR 880.2910
A clinical electronic thermometer is a device used to intermittently measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. This product code is class II exempt, and was exempted, subject to the limitations of exemption, under the procedures established by section 510(m) of the FD&C Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 880.9 and the specific limitations of exemption as stated in the final order, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
103 firms currently registered for this product code
Shijiazhuang Yide Medical Device Manufacturing Co., Ltd.
Shijiazhuang City Hebei, CN
Dongguan Simzo Electronic Technology Co., Ltd.
Dongguan Guangdong, CN
Shenzhen Yuezhongxing Technology Co.,ltd
Huizhou Guangdong, CN
Guangzhou Daxin Health Technology (dongguan) Co., Ltd
Dongguan City Guangdong, CN
Dongguan Polygreen Technology Co., Ltd.
DONGGUAN Guangdong, CN
Kimball Electronics - Thailand Ltd
Thungsukhla Sriracha Chon Buri, TH
Shenzhen Combei Technology Co.,ltd.
Shenzhen Guangdong, CN
Welch Allyn, Inc.
Skaneateles Falls, NY, US
Withings
Issy-les-Moulineaux Ile-de-France, FR
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Wenzhou Caretek Medical Device Co., Ltd
Wenzhou Zhejiang, CN
Bear Down Brands, Llc
Fullerton, CA, US
Schneider Asr B.v.
Rotterdam-Albrandswaard Zuid-Holland, NL
Ya Horng Electronic Co., Ltd.
Tainan, TW
Shenzhen Aspiron Technology Company Limited
Shenzhen Guangdong, CN
Cofoe Medical Technology Co.,ltd
Changsha Hunan, CN
Playhouse Method Inc. D/b/a Playhouse Md
Santa Monica, CA, US
Shenzhen Finicare Co., Ltd.
Shenzhen Guangdong, CN
Geon Corporation
CHANG HWA HSIEN Changhua, TW
O&m Halyard, Inc.
Alpharetta, GA, US
Guangdong Genial Technology Co., Ltd.
Zhaoqing Guangdong, CN
Easy Healthcare Corporation
Darien, IL, US
Cardinal Health
Norfolk, NE, US
Radiant Innovation Inc.
HSINCHU, TW
Huaian Zhongxin Packing Material Co., Ltd.
Huaian Jiangsu, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.