Product Code: FLL


Products Classified as FLL

2545Thermometer, Electronic, ClinicalClinical Electronic Thermometer.

Total Product Life Cycle (TPLC) Devices

2545Thermometer, Electronic, ClinicalClinical Electronic Thermometer.

FDA Consensus Standards

Thermometer, Electronic, Clinical [35719]21 CFR §880.2910 🔎
Thermometer, Electronic, Clinical [35718]21 CFR §880.2910 🔎
Thermometer, Electronic, Clinical [31332]21 CFR §880.2910 🔎
Thermometer, Electronic, Clinical [29658]21 CFR §880.2910 🔎
Thermometer, Electronic, Clinical [36930]21 CFR §880.2910 🔎

Pre-market Notifications for FLL

K201843Infrared Ear And Forehead Thermometer, Model YI-100Wenzhou Yosun Medical Technology Co., Ltd.
K201161Infrared Thermometer Model E127Bioland Technology Ltd.
K200802Infrared ThermometerShenzhen Urion Technology Co., Ltd
K200710Infrared PT2L Digital No-Touch ThermometerAndon Health Co., Ltd.
K200599Digital ThermometerJoytech Healthcare Co., Ltd
K200578Infrared Thermometer Model Number RN-50A,RN-50BNingbo Ranor Medical Science & Technology Co., Ltd.
K200531IHealth Infrared No-Touch Forehead ThermometerAndon Health Co., Ltd.
K200471Infrared Thermometer Model Number RN-60A,RN-60BNingbo Ranor Medical Science & Technology Co., Ltd.
K193625Disposable Temperature ProbeShenzhen Changke Connect Electronics Co., Ltd.
K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd.
K192210ESOTEST MULTI Esophageal Temperature Probe And Temperature Monitoring SystemFiab SpA
K191829Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH
K191668Infrared Forehead Thermometer (Model IR-FT)Comper Chuangxiang (Beijing) Technology Co., Ltd.
K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd.
K191283Infrared Thermometer, Breeze ModelSuzhou Melodicare Medical Technology Co.,Ltd.

Global Unique Device Identification Database

00606959021648Thermometer, electronic, clinical
20762012062714Thermometer, Electronic, Clinical
40525690022807Thermometer, Electronic, Clinical
40525690017810Thermometer, Electronic, Clinical
40525690015410Thermometer, Electronic, Clinical
40525690015403Thermometer, Electronic, Clinical
10400190272008Thermometer, Electronic, Clinical
10400119854704Thermometer, Electronic, Clinical
10400119854391Thermometer, Electronic, Clinical
00400104418228Thermometer, Electronic, Clinical
40387030022805Thermometer, Electronic, Clinical
40387030015418Thermometer, Electronic, Clinical
40387030015401Thermometer, Electronic, Clinical
00372217003014Thermometer, Electronic, Clinical
20370393421015Thermometer, Electronic, Clinical

Maude Adverse Events

BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2020-03-27
NOVAPLUS DIGITAL THERMOMETEREKLA CORPORATION2020-03-20
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2020-03-05
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2020-02-26
TOPCOSEJOY ELECTRONICS & INSTRUMENTS CO, LTD2020-02-20
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2020-02-12
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2020-01-30
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2020-01-14
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2020-01-14
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2020-01-14
S-CATH ESOPHAGEAL TEMPERATURE PROBECIRCA SCIENTIFIC2020-01-10
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2020-01-09
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2020-01-03
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-11-15
GENERAL PURPOSE PROBEDEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.2019-11-15
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-11-06
TOPCOSHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.2019-10-31
PHILIPS TEMPORAL TEMPERATURE HHPHILIPS MEDICAL SYSTEMS2019-10-31
BAIR HUGGER3M COMPANY2019-10-31
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-10-24
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-10-16
BAIR HUGGER3M COMPANY2019-10-16
GENERAL PURPOSE TEMPERATURE PROBE, SOFTDEROYAL INDUSTRIES, INC.2019-10-09
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-10-04
EXERGEN TEMPORAL SCANNEREXERGEN CORPORATION2019-10-03
TOPCOSHENZHEN DONGDIXIN TECHNOLOGY CO LTD2019-10-01
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-09-06
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-08-06
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-08-01
S-CATHCIRCA SCIENTIFIC, LLC2019-07-29
BRAUN THERMOSCAN PRO 6000WELCH ALLYN, INC.2019-07-26
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-07-19
TYMPANIC THERMOMETER BRAUN WELCH ALLYNBRAUN WELCH ALLYN / KAZ USA, INC.2019-07-11
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-07-02
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-06-26
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-06-26
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-06-06
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-05-16
MON-A-THERMMMJ SA DE CV (USD)2019-05-06
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-05-02
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-05-02
ARC DEVICES LTD INSTATEMP THERMOMETER OF TOMORROWARC DEVICES USA, INC.2019-04-30
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-04-17
ARC INSTA TEMPARC DEVICES USA, INC.2019-04-05
ARC INSTA TEMPARC DEVICES USA, INC.2019-04-05
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-04-04
VICKSONBO ELECTRONIC(SHENZHEN) CO.,LTD,2019-03-22
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-03-21
BRAUNKAZ USA, INC., A HELEN OF TROY COMPANY2019-03-21
VICKSKAZ USA, INC., A HELEN OF TROY COMPANY2019-03-13

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