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FDA 510(k)

MODEL 1000 ELECTRONIC CLINICAL THERMOMETER

K-Number: K885187 · 1989-03-08

ApplicantMon-A-Therm, Inc.
Decision Date1989-03-08
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL 1000 ELECTRONIC CLINICAL THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Mon-A-Therm, Inc.. It received FDA 510(k) clearance on 1989-03-08 under 510(k) number K885187. 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 MODEL 1000 ELECTRONIC CLINICAL THERMOMETER?

MODEL 1000 ELECTRONIC CLINICAL THERMOMETER is a medical device that received FDA 510(k) clearance on 1989-03-08. The listed applicant is Mon-A-Therm, Inc.. The 510(k) number is K885187.

When did MODEL 1000 ELECTRONIC CLINICAL THERMOMETER receive FDA 510(k) clearance?

MODEL 1000 ELECTRONIC CLINICAL THERMOMETER received FDA 510(k) clearance on 1989-03-08, under 510(k) number K885187.

Who is the listed applicant for MODEL 1000 ELECTRONIC CLINICAL THERMOMETER?

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

What is the FDA product code for MODEL 1000 ELECTRONIC CLINICAL THERMOMETER?

The FDA product code for MODEL 1000 ELECTRONIC CLINICAL THERMOMETER is FLL.

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Other records listing Mon-A-Therm, 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.

K874519MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSORK874522MODIFIED MYOCARDIAL TEMPERATURE SENSORK875234MON-A-THERM'S SKIN TEMPERATURE SENSORK874523MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSORK874524MODIFIED SUBCUTANEOUS TEMPERATURE SENSORK874521MODIFIED THERMAL WELL TEMPERATURE SENSOR

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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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