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FDA 510(k)

DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A

K-Number: K955142 · 1995-12-29

ApplicantSalutron, Inc.
Decision Date1995-12-29
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A is the device name listed in this FDA 510(k) record. The listed applicant is Salutron, Inc.. It received FDA 510(k) clearance on 1995-12-29 under 510(k) number K955142. 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 DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A?

DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A is a medical device that received FDA 510(k) clearance on 1995-12-29. The listed applicant is Salutron, Inc.. The 510(k) number is K955142.

When did DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A receive FDA 510(k) clearance?

DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A received FDA 510(k) clearance on 1995-12-29, under 510(k) number K955142.

Who is the listed applicant for DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A?

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

What is the FDA product code for DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A?

The FDA product code for DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A 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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