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FDA 510(k)

ESCORT II CLINICAL THERMOMETRY MODULE (CTM)

K-Number: K970011 · 1997-07-09

ApplicantMedical Data Electronics
Decision Date1997-07-09
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ESCORT II CLINICAL THERMOMETRY MODULE (CTM) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Data Electronics. It received FDA 510(k) clearance on 1997-07-09 under 510(k) number K970011. 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 ESCORT II CLINICAL THERMOMETRY MODULE (CTM)?

ESCORT II CLINICAL THERMOMETRY MODULE (CTM) is a medical device that received FDA 510(k) clearance on 1997-07-09. The listed applicant is Medical Data Electronics. The 510(k) number is K970011.

When did ESCORT II CLINICAL THERMOMETRY MODULE (CTM) receive FDA 510(k) clearance?

ESCORT II CLINICAL THERMOMETRY MODULE (CTM) received FDA 510(k) clearance on 1997-07-09, under 510(k) number K970011.

Who is the listed applicant for ESCORT II CLINICAL THERMOMETRY MODULE (CTM)?

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

What is the FDA product code for ESCORT II CLINICAL THERMOMETRY MODULE (CTM)?

The FDA product code for ESCORT II CLINICAL THERMOMETRY MODULE (CTM) is FLL.

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Other records listing Medical Data Electronics 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.

K014294MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414K012336MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413K992413ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITORK992411ESCORT II+ 400 SERIES (ESCORT PRISM) MONITORK982104ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500

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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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