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FDA 510(k)

HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA

K-Number: K864089 · 1986-11-07

ApplicantHitachi Sales Corporation of America
Decision Date1986-11-07
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Sales Corporation of America. It received FDA 510(k) clearance on 1986-11-07 under 510(k) number K864089. 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 HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA?

HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA is a medical device that received FDA 510(k) clearance on 1986-11-07. The listed applicant is Hitachi Sales Corporation of America. The 510(k) number is K864089.

When did HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA receive FDA 510(k) clearance?

HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA received FDA 510(k) clearance on 1986-11-07, under 510(k) number K864089.

Who is the listed applicant for HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA?

The FDA 510(k) record lists Hitachi Sales Corporation of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA?

The FDA product code for HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA 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 Hitachi Sales Corporation of America 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.

K864088HITACHI HAND HELD MASSAGER A/C POWERED

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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