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FDA 510(k)

LUMISCOPE MODEL 2018 THERMOMETER

K-Number: K954792 · 1996-06-21

ApplicantLumiscope Co., Inc.
Decision Date1996-06-21
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LUMISCOPE MODEL 2018 THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Lumiscope Co., Inc.. It received FDA 510(k) clearance on 1996-06-21 under 510(k) number K954792. 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 LUMISCOPE MODEL 2018 THERMOMETER?

LUMISCOPE MODEL 2018 THERMOMETER is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Lumiscope Co., Inc.. The 510(k) number is K954792.

When did LUMISCOPE MODEL 2018 THERMOMETER receive FDA 510(k) clearance?

LUMISCOPE MODEL 2018 THERMOMETER received FDA 510(k) clearance on 1996-06-21, under 510(k) number K954792.

Who is the listed applicant for LUMISCOPE MODEL 2018 THERMOMETER?

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

What is the FDA product code for LUMISCOPE MODEL 2018 THERMOMETER?

The FDA product code for LUMISCOPE MODEL 2018 THERMOMETER is FLL.

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Other records listing Lumiscope Co., Inc. 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.

K032714CARDICARE MODEL MT-301F & MT-301CK931768INTERFERENTIAL CURRENT THERAPY UNITK925054INFRARED LAMPK924081LUMISONICK920099GYMMANK901849LUMISCOPE EMS 8000

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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

View on FDA Database →

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

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