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FDA 510(k)

SERIES 400 DISPOSABLE TEMPERATURE PROBE

K-Number: K813639 · 1982-01-22

ApplicantYellow Springs Instrument Co., Inc.
Decision Date1982-01-22
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SERIES 400 DISPOSABLE TEMPERATURE PROBE 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 1982-01-22 under 510(k) number K813639. 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 SERIES 400 DISPOSABLE TEMPERATURE PROBE?

SERIES 400 DISPOSABLE TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Yellow Springs Instrument Co., Inc.. The 510(k) number is K813639.

When did SERIES 400 DISPOSABLE TEMPERATURE PROBE receive FDA 510(k) clearance?

SERIES 400 DISPOSABLE TEMPERATURE PROBE received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813639.

Who is the listed applicant for SERIES 400 DISPOSABLE TEMPERATURE PROBE?

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 SERIES 400 DISPOSABLE TEMPERATURE PROBE?

The FDA product code for SERIES 400 DISPOSABLE TEMPERATURE PROBE is FLL.

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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

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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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