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FDA 510(k)

HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE

K-Number: K890484 · 1989-04-21

ApplicantMallinckrodt Anesthesia Products
Decision Date1989-04-21
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Anesthesia Products. It received FDA 510(k) clearance on 1989-04-21 under 510(k) number K890484. 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 GENERAL PURPOSE TEMPERATURE PROBE?

HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 1989-04-21. The listed applicant is Mallinckrodt Anesthesia Products. The 510(k) number is K890484.

When did HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE receive FDA 510(k) clearance?

HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE received FDA 510(k) clearance on 1989-04-21, under 510(k) number K890484.

Who is the listed applicant for HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE?

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

What is the FDA product code for HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE?

The FDA product code for HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE 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 Mallinckrodt Anesthesia Products 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.

K912240CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEMK895875MODEL 4070 TEMPERATURE MONITOR

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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