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FDA 510(k)

STAT TEMP MODEL 4800

K-Number: K800396 · 1980-03-25

ApplicantBaessler Medical Electronics,Inc.
Decision Date1980-03-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STAT TEMP MODEL 4800 is the device name listed in this FDA 510(k) record. The listed applicant is Baessler Medical Electronics,Inc.. It received FDA 510(k) clearance on 1980-03-25 under 510(k) number K800396. 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 STAT TEMP MODEL 4800?

STAT TEMP MODEL 4800 is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is Baessler Medical Electronics,Inc.. The 510(k) number is K800396.

When did STAT TEMP MODEL 4800 receive FDA 510(k) clearance?

STAT TEMP MODEL 4800 received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800396.

Who is the listed applicant for STAT TEMP MODEL 4800?

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

What is the FDA product code for STAT TEMP MODEL 4800?

The FDA product code for STAT TEMP MODEL 4800 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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