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FDA 510(k)

FORTEC MI-305

K-Number: K851873 · 1985-05-13

ApplicantNam Tai , Ltd.
Decision Date1985-05-13
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FORTEC MI-305 is the device name listed in this FDA 510(k) record. The listed applicant is Nam Tai , Ltd.. It received FDA 510(k) clearance on 1985-05-13 under 510(k) number K851873. 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 FORTEC MI-305?

FORTEC MI-305 is a medical device that received FDA 510(k) clearance on 1985-05-13. The listed applicant is Nam Tai , Ltd.. The 510(k) number is K851873.

When did FORTEC MI-305 receive FDA 510(k) clearance?

FORTEC MI-305 received FDA 510(k) clearance on 1985-05-13, under 510(k) number K851873.

Who is the listed applicant for FORTEC MI-305?

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

What is the FDA product code for FORTEC MI-305?

The FDA product code for FORTEC MI-305 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 Nam Tai , 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.

K873765FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METERK872584FORTEC MI-306, MI-327 DIGITAL THERMOMETERK853317FORTEC MI-305 & 306 DIGITAL THERMOMETER

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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