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FDA 510(k)

SURVALENT II ORAL THERMOMETER

K-Number: K923289 · 1993-10-21

ApplicantEpson America, Inc.
Decision Date1993-10-21
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURVALENT II ORAL THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Epson America, Inc.. It received FDA 510(k) clearance on 1993-10-21 under 510(k) number K923289. 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 SURVALENT II ORAL THERMOMETER?

SURVALENT II ORAL THERMOMETER is a medical device that received FDA 510(k) clearance on 1993-10-21. The listed applicant is Epson America, Inc.. The 510(k) number is K923289.

When did SURVALENT II ORAL THERMOMETER receive FDA 510(k) clearance?

SURVALENT II ORAL THERMOMETER received FDA 510(k) clearance on 1993-10-21, under 510(k) number K923289.

Who is the listed applicant for SURVALENT II ORAL THERMOMETER?

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

What is the FDA product code for SURVALENT II ORAL THERMOMETER?

The FDA product code for SURVALENT II ORAL THERMOMETER is FLL.

Related Clinical Trials

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Other records listing Epson America, Inc. 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.

K880759MODIFIED DIGITAL CLINICAL THERMOMETERK853824DIGITAL THERMOMETER

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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