Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Digital Thermometer

K-Number: K161211 · 2016-08-29

ApplicantBiocare Asia Corporation , Ltd.
Decision Date2016-08-29
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Digital Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Biocare Asia Corporation , Ltd.. It received FDA 510(k) clearance on 2016-08-29 under 510(k) number K161211. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Thermometer?

Digital Thermometer is a medical device that received FDA 510(k) clearance on 2016-08-29. The listed applicant is Biocare Asia Corporation , Ltd.. The 510(k) number is K161211.

When did Digital Thermometer receive FDA 510(k) clearance?

Digital Thermometer received FDA 510(k) clearance on 2016-08-29, under 510(k) number K161211.

Who is the listed applicant for Digital Thermometer?

The FDA 510(k) record lists Biocare Asia Corporation , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Thermometer?

The FDA product code for Digital Thermometer is FLL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05935306Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic SurgeryCOMPLETED

Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑