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FDA 510(k)

FIRSTTEMP GENIUS

K-Number: K920713 · 1992-12-17

ApplicantIntelligent Medical Systems
Decision Date1992-12-17
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FIRSTTEMP GENIUS is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Medical Systems. It received FDA 510(k) clearance on 1992-12-17 under 510(k) number K920713. 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 FIRSTTEMP GENIUS?

FIRSTTEMP GENIUS is a medical device that received FDA 510(k) clearance on 1992-12-17. The listed applicant is Intelligent Medical Systems. The 510(k) number is K920713.

When did FIRSTTEMP GENIUS receive FDA 510(k) clearance?

FIRSTTEMP GENIUS received FDA 510(k) clearance on 1992-12-17, under 510(k) number K920713.

Who is the listed applicant for FIRSTTEMP GENIUS?

The FDA 510(k) record lists Intelligent Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIRSTTEMP GENIUS?

The FDA product code for FIRSTTEMP GENIUS is FLL.

Related Clinical Trials

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.

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Other records listing Intelligent Medical Systems 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.

K853713FIRST TEMP

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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