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FDA 510(k)

PATIENT TEMPERATURE MONITOR, MODEL 1000

K-Number: K874159 · 1987-11-23

ApplicantSonodyne America, Ltd.
Decision Date1987-11-23
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT TEMPERATURE MONITOR, MODEL 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Sonodyne America, Ltd.. It received FDA 510(k) clearance on 1987-11-23 under 510(k) number K874159. 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 PATIENT TEMPERATURE MONITOR, MODEL 1000?

PATIENT TEMPERATURE MONITOR, MODEL 1000 is a medical device that received FDA 510(k) clearance on 1987-11-23. The listed applicant is Sonodyne America, Ltd.. The 510(k) number is K874159.

When did PATIENT TEMPERATURE MONITOR, MODEL 1000 receive FDA 510(k) clearance?

PATIENT TEMPERATURE MONITOR, MODEL 1000 received FDA 510(k) clearance on 1987-11-23, under 510(k) number K874159.

Who is the listed applicant for PATIENT TEMPERATURE MONITOR, MODEL 1000?

The FDA 510(k) record lists Sonodyne America, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATIENT TEMPERATURE MONITOR, MODEL 1000?

The FDA product code for PATIENT TEMPERATURE MONITOR, MODEL 1000 is FLL.

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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

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