FDA 510(k)

TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201

K-Number: K984497 · 1999-05-26

ApplicantOriental System Technology, Inc.

Decision Date1999-05-26

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 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 1999-05-26 under 510(k) number K984497. 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 TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201?

TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 is a medical device that received FDA 510(k) clearance on 1999-05-26. The listed applicant is Oriental System Technology, Inc.. The 510(k) number is K984497.

When did TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 receive FDA 510(k) clearance?

TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 received FDA 510(k) clearance on 1999-05-26, under 510(k) number K984497.

Who is the listed applicant for TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201?

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 TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201?

The FDA product code for TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 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 K001008TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 K992601TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203

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