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FDA 510(k)

CLINICAL VOICE THERMOMETER

K-Number: K935466 · 1995-04-13

ApplicantBlazie Engineering, Inc.
Decision Date1995-04-13
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLINICAL VOICE THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Blazie Engineering, Inc.. It received FDA 510(k) clearance on 1995-04-13 under 510(k) number K935466. 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 CLINICAL VOICE THERMOMETER?

CLINICAL VOICE THERMOMETER is a medical device that received FDA 510(k) clearance on 1995-04-13. The listed applicant is Blazie Engineering, Inc.. The 510(k) number is K935466.

When did CLINICAL VOICE THERMOMETER receive FDA 510(k) clearance?

CLINICAL VOICE THERMOMETER received FDA 510(k) clearance on 1995-04-13, under 510(k) number K935466.

Who is the listed applicant for CLINICAL VOICE THERMOMETER?

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

What is the FDA product code for CLINICAL VOICE THERMOMETER?

The FDA product code for CLINICAL VOICE 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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