Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER

K-Number: K813409 · 1981-12-18

ApplicantYellow Springs Instrument Co., Inc.
Decision Date1981-12-18
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Yellow Springs Instrument Co., Inc.. It received FDA 510(k) clearance on 1981-12-18 under 510(k) number K813409. 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 MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER?

MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER is a medical device that received FDA 510(k) clearance on 1981-12-18. The listed applicant is Yellow Springs Instrument Co., Inc.. The 510(k) number is K813409.

When did MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER receive FDA 510(k) clearance?

MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER received FDA 510(k) clearance on 1981-12-18, under 510(k) number K813409.

Who is the listed applicant for MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER?

The FDA 510(k) record lists Yellow Springs Instrument Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER?

The FDA product code for MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Yellow Springs Instrument Co., Inc. 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.

K962070YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBEK922821YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBESK922007YSI MODEL 441A AIRWAY TEMPERATURE PROBEK910633YSI MODEL 1500 BLOOD GLUCOSE ANALYZERK910718YSI PRECISION 4000 THERMOMETERK901131YSI MODEL 1500 SPORT L-LACTATE ANALYZER

View all 23 devices →

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.

↑