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FDA 510(k)

FEVER MONITORING KIT

K-Number: K931747 · 1993-12-13

ApplicantPolymedica Healthcare, Inc.
Decision Date1993-12-13
Product CodeFLL
Advisory CommitteeHO
DecisionUnknown

Device Summary

FEVER MONITORING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Polymedica Healthcare, Inc.. It received FDA 510(k) clearance on 1993-12-13 under 510(k) number K931747. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the FEVER MONITORING KIT?

FEVER MONITORING KIT is a medical device that received FDA 510(k) clearance on 1993-12-13. The listed applicant is Polymedica Healthcare, Inc.. The 510(k) number is K931747.

When did FEVER MONITORING KIT receive FDA 510(k) clearance?

FEVER MONITORING KIT received FDA 510(k) clearance on 1993-12-13, under 510(k) number K931747.

Who is the listed applicant for FEVER MONITORING KIT?

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

What is the FDA product code for FEVER MONITORING KIT?

The FDA product code for FEVER MONITORING KIT 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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