FDA 510(k)

HI-LO TEMP GEN. PURPOSE TEMP. PROBE

K-Number: K801924 · 1980-09-09

ApplicantNational Catheter Co. Div. Mallinckrodt

Decision Date1980-09-09

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HI-LO TEMP GEN. PURPOSE TEMP. PROBE is the device name listed in this FDA 510(k) record. The listed applicant is National Catheter Co. Div. Mallinckrodt. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801924. 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 GEN. PURPOSE TEMP. PROBE?

HI-LO TEMP GEN. PURPOSE TEMP. PROBE is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is National Catheter Co. Div. Mallinckrodt. The 510(k) number is K801924.

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

HI-LO TEMP GEN. PURPOSE TEMP. PROBE received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801924.

Who is the listed applicant for HI-LO TEMP GEN. PURPOSE TEMP. PROBE?

The FDA 510(k) record lists National Catheter Co. Div. Mallinckrodt as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI-LO TEMP GEN. PURPOSE TEMP. PROBE?

The FDA product code for HI-LO TEMP GEN. PURPOSE TEMP. 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing National Catheter Co. Div. Mallinckrodt as applicant

K802918ANTHRON CATHETER SET K802505DOUBLE LUMEN TRACHEAL TUBE K810321REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)K801005MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)K791190STETHOSCOPE WITH TEMPERATURE SENSOR K781665TUBE, LEATHERMAN/IMBRUCE

View all 8 devices →

Related Devices (Code: FLL)

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.