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FDA 510(k)

GERATHERM BABYWATCH TEMPERATURE MONITOR

K-Number: K001281 · 2001-06-12

ApplicantGeratherm AG
Decision Date2001-06-12
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GERATHERM BABYWATCH TEMPERATURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Geratherm AG. It received FDA 510(k) clearance on 2001-06-12 under 510(k) number K001281. 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 GERATHERM BABYWATCH TEMPERATURE MONITOR?

GERATHERM BABYWATCH TEMPERATURE MONITOR is a medical device that received FDA 510(k) clearance on 2001-06-12. The listed applicant is Geratherm AG. The 510(k) number is K001281.

When did GERATHERM BABYWATCH TEMPERATURE MONITOR receive FDA 510(k) clearance?

GERATHERM BABYWATCH TEMPERATURE MONITOR received FDA 510(k) clearance on 2001-06-12, under 510(k) number K001281.

Who is the listed applicant for GERATHERM BABYWATCH TEMPERATURE MONITOR?

The FDA 510(k) record lists Geratherm AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GERATHERM BABYWATCH TEMPERATURE MONITOR?

The FDA product code for GERATHERM BABYWATCH TEMPERATURE MONITOR 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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