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FDA 510(k)

HI-LO TEMP TYMPANIC TEMP. SENSOR

K-Number: K832635 · 1983-10-04

ApplicantMallinckrodt Critical Care
Decision Date1983-10-04
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HI-LO TEMP TYMPANIC TEMP. 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 1983-10-04 under 510(k) number K832635. 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 TYMPANIC TEMP. SENSOR?

HI-LO TEMP TYMPANIC TEMP. SENSOR is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K832635.

When did HI-LO TEMP TYMPANIC TEMP. SENSOR receive FDA 510(k) clearance?

HI-LO TEMP TYMPANIC TEMP. SENSOR received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832635.

Who is the listed applicant for HI-LO TEMP TYMPANIC TEMP. 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 TYMPANIC TEMP. SENSOR?

The FDA product code for HI-LO TEMP TYMPANIC TEMP. 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 MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

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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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