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FDA 510(k)

CHECK MATE #1850 ELEC. DIGITAL THERMO

K-Number: K823493 · 1983-02-28

ApplicantBristoline, Inc.
Decision Date1983-02-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHECK MATE #1850 ELEC. DIGITAL THERMO is the device name listed in this FDA 510(k) record. The listed applicant is Bristoline, Inc.. It received FDA 510(k) clearance on 1983-02-28 under 510(k) number K823493. 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 CHECK MATE #1850 ELEC. DIGITAL THERMO?

CHECK MATE #1850 ELEC. DIGITAL THERMO is a medical device that received FDA 510(k) clearance on 1983-02-28. The listed applicant is Bristoline, Inc.. The 510(k) number is K823493.

When did CHECK MATE #1850 ELEC. DIGITAL THERMO receive FDA 510(k) clearance?

CHECK MATE #1850 ELEC. DIGITAL THERMO received FDA 510(k) clearance on 1983-02-28, under 510(k) number K823493.

Who is the listed applicant for CHECK MATE #1850 ELEC. DIGITAL THERMO?

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

What is the FDA product code for CHECK MATE #1850 ELEC. DIGITAL THERMO?

The FDA product code for CHECK MATE #1850 ELEC. DIGITAL THERMO is FLL.

Related Clinical Trials

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.

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Other records listing Bristoline, 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.

K770921SPHYGMOMANOMETER, ELECTRONIC

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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