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FDA 510(k)

ELECTRONIC CLINICAL THERMOMETER TEMP PR

K-Number: K820409 · 1982-03-02

ApplicantY
Decision Date1982-03-02
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC CLINICAL THERMOMETER TEMP PR is the device name listed in this FDA 510(k) record. The listed applicant is Y. It received FDA 510(k) clearance on 1982-03-02 under 510(k) number K820409. 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 ELECTRONIC CLINICAL THERMOMETER TEMP PR?

ELECTRONIC CLINICAL THERMOMETER TEMP PR is a medical device that received FDA 510(k) clearance on 1982-03-02. The listed applicant is Y. The 510(k) number is K820409.

When did ELECTRONIC CLINICAL THERMOMETER TEMP PR receive FDA 510(k) clearance?

ELECTRONIC CLINICAL THERMOMETER TEMP PR received FDA 510(k) clearance on 1982-03-02, under 510(k) number K820409.

Who is the listed applicant for ELECTRONIC CLINICAL THERMOMETER TEMP PR?

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

What is the FDA product code for ELECTRONIC CLINICAL THERMOMETER TEMP PR?

The FDA product code for ELECTRONIC CLINICAL THERMOMETER TEMP PR is FLL.

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Other records listing Y 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.

K955846MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETERK960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSK953225IVAC BALL VALCE ADMIN. SETSK934095IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETSK940897IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SETK931550EZ ADMINISTRATION SET

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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

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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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