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

K221170Forehead Thermometer, Models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107Shenzhen AOJ Medical Technology Co., Ltd.
K213485Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D And AOJ-25EShenzhen AOJ Medical Technology Co., Ltd.
K213079Ear Thermometer, Model ET001Guangzhou Berrcom Medical Device Co., Ltd.
K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311Guangzhou Berrcom Medical Device Co., Ltd.
K213084Ear Thermometer, Model ET005, ET008, ET009Guangzhou Berrcom Medical Device Co., Ltd.
K213038Infrared Forehead Thermometer, Model: HS-9802DJiaxing Shangjia Intelligence Technology Co., Ltd.
K212598IHealth Infrared Ear Thermometer PT5Andon Health Co., Ltd.
K212346Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618Shenzhen Pango Medical Electronics Co., Ltd.
K212257Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311Alicn Medical Shenzhen, Inc.
K211744Non-Contact Infrared Thermometer, Model HL710HHealth & Life Co., Ltd
K211752Infrared ThermometerBeijing Choice Electronic Technology Co., Ltd.
K211629Infrared Forehead Thermometer LD-FT-100BHonsun (Nantong) Co., Ltd
K211583Infrared Thermometer, Model: HW-1Dongguan SIMZO Electronic Technology Co.Ltd.
K211352Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd.
K210937Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241Alicn Medical Shenzhen, Inc.

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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