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FDA 510(k)

PACIFIER THERMOMETER

K-Number: K952541 · 1996-01-02

ApplicantRegitar U.S.A., Inc.
Decision Date1996-01-02
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PACIFIER THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Regitar U.S.A., Inc.. It received FDA 510(k) clearance on 1996-01-02 under 510(k) number K952541. 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 PACIFIER THERMOMETER?

PACIFIER THERMOMETER is a medical device that received FDA 510(k) clearance on 1996-01-02. The listed applicant is Regitar U.S.A., Inc.. The 510(k) number is K952541.

When did PACIFIER THERMOMETER receive FDA 510(k) clearance?

PACIFIER THERMOMETER received FDA 510(k) clearance on 1996-01-02, under 510(k) number K952541.

Who is the listed applicant for PACIFIER THERMOMETER?

The FDA 510(k) record lists Regitar U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACIFIER THERMOMETER?

The FDA product code for PACIFIER THERMOMETER 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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