Decision Date2020-12-03
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
TempTraq is the device name listed in this FDA 510(k) record. The listed applicant is Blue Spark Technologies, Inc.. It received FDA 510(k) clearance on 2020-12-03 under 510(k) number K201977. 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 TempTraq?
TempTraq is a medical device that received FDA 510(k) clearance on 2020-12-03. The listed applicant is Blue Spark Technologies, Inc.. The 510(k) number is K201977.
When did TempTraq receive FDA 510(k) clearance?
TempTraq received FDA 510(k) clearance on 2020-12-03, under 510(k) number K201977.
Who is the listed applicant for TempTraq?
The FDA 510(k) record lists Blue Spark Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TempTraq?
The FDA product code for TempTraq is FLL.
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.