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FDA 510(k)

ELECTRONIC CLINICAL THERM. MODEL 811A

K-Number: K800512 · 1980-03-25

ApplicantY
Decision Date1980-03-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC CLINICAL THERM. MODEL 811A is the device name listed in this FDA 510(k) record. The listed applicant is Y. It received FDA 510(k) clearance on 1980-03-25 under 510(k) number K800512. 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 THERM. MODEL 811A?

ELECTRONIC CLINICAL THERM. MODEL 811A is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is Y. The 510(k) number is K800512.

When did ELECTRONIC CLINICAL THERM. MODEL 811A receive FDA 510(k) clearance?

ELECTRONIC CLINICAL THERM. MODEL 811A received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800512.

Who is the listed applicant for ELECTRONIC CLINICAL THERM. MODEL 811A?

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 THERM. MODEL 811A?

The FDA product code for ELECTRONIC CLINICAL THERM. MODEL 811A is FLL.

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Other records listing Y as applicant

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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