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FDA 510(k)

MODEL THERMO TEK QUICKCARE

K-Number: K010502 · 2001-02-27

ApplicantSaat , Ltd.
Decision Date2001-02-27
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL THERMO TEK QUICKCARE is the device name listed in this FDA 510(k) record. The listed applicant is Saat , Ltd.. It received FDA 510(k) clearance on 2001-02-27 under 510(k) number K010502. 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 MODEL THERMO TEK QUICKCARE?

MODEL THERMO TEK QUICKCARE is a medical device that received FDA 510(k) clearance on 2001-02-27. The listed applicant is Saat , Ltd.. The 510(k) number is K010502.

When did MODEL THERMO TEK QUICKCARE receive FDA 510(k) clearance?

MODEL THERMO TEK QUICKCARE received FDA 510(k) clearance on 2001-02-27, under 510(k) number K010502.

Who is the listed applicant for MODEL THERMO TEK QUICKCARE?

The FDA 510(k) record lists Saat , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL THERMO TEK QUICKCARE?

The FDA product code for MODEL THERMO TEK QUICKCARE is FLL.

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Other records listing Saat , Ltd. as applicant

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.

K041646THERMOTEK Q5K002712THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F

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

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

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