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FDA 510(k)

ESOPHAGEAL RECTAL TEMPERATURE PROBE

K-Number: K863646 · 1986-11-25

ApplicantRespiratory Support Products, Inc.
Decision Date1986-11-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL RECTAL TEMPERATURE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Support Products, Inc.. It received FDA 510(k) clearance on 1986-11-25 under 510(k) number K863646. 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 ESOPHAGEAL RECTAL TEMPERATURE PROBE?

ESOPHAGEAL RECTAL TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 1986-11-25. The listed applicant is Respiratory Support Products, Inc.. The 510(k) number is K863646.

When did ESOPHAGEAL RECTAL TEMPERATURE PROBE receive FDA 510(k) clearance?

ESOPHAGEAL RECTAL TEMPERATURE PROBE received FDA 510(k) clearance on 1986-11-25, under 510(k) number K863646.

Who is the listed applicant for ESOPHAGEAL RECTAL TEMPERATURE PROBE?

The FDA 510(k) record lists Respiratory Support Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESOPHAGEAL RECTAL TEMPERATURE PROBE?

The FDA product code for ESOPHAGEAL RECTAL TEMPERATURE PROBE is FLL.

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Other records listing Respiratory Support Products, Inc. as applicant

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K983862CLOUD 1 HUMIDIFICATION SYSTEMK921190ADAP-TEMP TEMPERATURE SENSOR ADAPTERK920469MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIEK921510GAS SAMPLING KIT MODIFICATIONK913082BI-TEMP TEMPERATURE MONITOR,MODEL TM-300DK912280BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D

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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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