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FDA 510(k)

ENTRACARE THERMOMTER MODEL 1000

K-Number: K964851 · 1997-02-03

ApplicantEntracare Corp.
Decision Date1997-02-03
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ENTRACARE THERMOMTER MODEL 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Entracare Corp.. It received FDA 510(k) clearance on 1997-02-03 under 510(k) number K964851. 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 ENTRACARE THERMOMTER MODEL 1000?

ENTRACARE THERMOMTER MODEL 1000 is a medical device that received FDA 510(k) clearance on 1997-02-03. The listed applicant is Entracare Corp.. The 510(k) number is K964851.

When did ENTRACARE THERMOMTER MODEL 1000 receive FDA 510(k) clearance?

ENTRACARE THERMOMTER MODEL 1000 received FDA 510(k) clearance on 1997-02-03, under 510(k) number K964851.

Who is the listed applicant for ENTRACARE THERMOMTER MODEL 1000?

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

What is the FDA product code for ENTRACARE THERMOMTER MODEL 1000?

The FDA product code for ENTRACARE THERMOMTER MODEL 1000 is FLL.

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Other records listing Entracare Corp. 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.

K952671RATESAVER PLUSK925261NUTRICARE ENTERAL FEEDING TUBE

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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