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FDA 510(k)

TERPERATUR SENSING DEVICE

K-Number: K802607 · 1980-11-19

ApplicantBurditt & Calkins-Siemens-Elema
Decision Date1980-11-19
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TERPERATUR SENSING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Burditt & Calkins-Siemens-Elema. It received FDA 510(k) clearance on 1980-11-19 under 510(k) number K802607. 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 TERPERATUR SENSING DEVICE?

TERPERATUR SENSING DEVICE is a medical device that received FDA 510(k) clearance on 1980-11-19. The listed applicant is Burditt & Calkins-Siemens-Elema. The 510(k) number is K802607.

When did TERPERATUR SENSING DEVICE receive FDA 510(k) clearance?

TERPERATUR SENSING DEVICE received FDA 510(k) clearance on 1980-11-19, under 510(k) number K802607.

Who is the listed applicant for TERPERATUR SENSING DEVICE?

The FDA 510(k) record lists Burditt & Calkins-Siemens-Elema as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TERPERATUR SENSING DEVICE?

The FDA product code for TERPERATUR SENSING DEVICE is FLL.

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Other records listing Burditt & Calkins-Siemens-Elema as applicant

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K833519PULSE GENERATOR MODEL 688K833155RAYDEN MEDICAL MINI PULSE VOLUME RECORDK830344SIEMENS-ELMA PULSE GENERATOR #718K823435MON-A-THERM MYOCARDIAL TEMP. SENSORK823591AMEDA HAND BREAST PUMPK822239COAXIAL BIPOLAR PACING ELECTRODE

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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