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FDA 510(k)

BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D

K-Number: K912280 · 1991-10-17

ApplicantRespiratory Support Products, Inc.
Decision Date1991-10-17
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D 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 1991-10-17 under 510(k) number K912280. 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 BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D?

BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D is a medical device that received FDA 510(k) clearance on 1991-10-17. The listed applicant is Respiratory Support Products, Inc.. The 510(k) number is K912280.

When did BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D receive FDA 510(k) clearance?

BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D received FDA 510(k) clearance on 1991-10-17, under 510(k) number K912280.

Who is the listed applicant for BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D?

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 BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D?

The FDA product code for BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D is FLL.

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Other records listing Respiratory Support Products, 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.

K983862CLOUD 1 HUMIDIFICATION SYSTEMK921190ADAP-TEMP TEMPERATURE SENSOR ADAPTERK920469MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIEK921510GAS SAMPLING KIT MODIFICATIONK913082BI-TEMP TEMPERATURE MONITOR,MODEL TM-300DK913083BI-TEMP TEMPERATURE MONITOR TM-201D

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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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