FDA 510(k)

TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921

K-Number: K001008 · 2000-04-12

ApplicantOriental System Technology, Inc.

Decision Date2000-04-12

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 is the device name listed in this FDA 510(k) record. The listed applicant is Oriental System Technology, Inc.. It received FDA 510(k) clearance on 2000-04-12 under 510(k) number K001008. 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 TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921?

TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 is a medical device that received FDA 510(k) clearance on 2000-04-12. The listed applicant is Oriental System Technology, Inc.. The 510(k) number is K001008.

When did TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 receive FDA 510(k) clearance?

TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 received FDA 510(k) clearance on 2000-04-12, under 510(k) number K001008.

Who is the listed applicant for TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921?

The FDA 510(k) record lists Oriental System Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921?

The FDA product code for TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 is FLL.

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Other records listing Oriental System Technology, Inc. as applicant

K042202TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502 K030299TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX K010235TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX K992601TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203 K984497TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201

Related Devices (Code: FLL)

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

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