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FDA 510(k)

HI-LO TEMP SKIN TEMPERATURE SENSOR

K-Number: K821833 · 1982-07-20

ApplicantMallinckrodt Critical Care
Decision Date1982-07-20
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HI-LO TEMP SKIN TEMPERATURE SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1982-07-20 under 510(k) number K821833. 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 HI-LO TEMP SKIN TEMPERATURE SENSOR?

HI-LO TEMP SKIN TEMPERATURE SENSOR is a medical device that received FDA 510(k) clearance on 1982-07-20. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K821833.

When did HI-LO TEMP SKIN TEMPERATURE SENSOR receive FDA 510(k) clearance?

HI-LO TEMP SKIN TEMPERATURE SENSOR received FDA 510(k) clearance on 1982-07-20, under 510(k) number K821833.

Who is the listed applicant for HI-LO TEMP SKIN TEMPERATURE SENSOR?

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

What is the FDA product code for HI-LO TEMP SKIN TEMPERATURE SENSOR?

The FDA product code for HI-LO TEMP SKIN TEMPERATURE SENSOR is FLL.

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Other records listing Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK874404HI-LO TEMP(R) SKIN TEMPERATURE SENSORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)

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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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