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FDA 510(k)

FIRST TEMP

K-Number: K853713 · 1985-11-01

ApplicantIntelligent Medical Systems
Decision Date1985-11-01
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FIRST TEMP 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 1985-11-01 under 510(k) number K853713. 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 FIRST TEMP?

FIRST TEMP is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Intelligent Medical Systems. The 510(k) number is K853713.

When did FIRST TEMP receive FDA 510(k) clearance?

FIRST TEMP received FDA 510(k) clearance on 1985-11-01, under 510(k) number K853713.

Who is the listed applicant for FIRST TEMP?

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 FIRST TEMP?

The FDA product code for FIRST TEMP 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K920713FIRSTTEMP GENIUS

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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