FDA 510(k)

ESCORT MODEL 400T TELEMETRY ECG MONITOR

K-Number: K902254 · 1990-07-27

Decision Date1990-07-27

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ESCORT MODEL 400T TELEMETRY ECG MONITOR 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 1990-07-27 under 510(k) number K902254. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESCORT MODEL 400T TELEMETRY ECG MONITOR?

ESCORT MODEL 400T TELEMETRY ECG MONITOR is a medical device that received FDA 510(k) clearance on 1990-07-27. The listed applicant is Medical Data Electronics. The 510(k) number is K902254.

When did ESCORT MODEL 400T TELEMETRY ECG MONITOR receive FDA 510(k) clearance?

ESCORT MODEL 400T TELEMETRY ECG MONITOR received FDA 510(k) clearance on 1990-07-27, under 510(k) number K902254.

Who is the listed applicant for ESCORT MODEL 400T TELEMETRY ECG MONITOR?

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 MODEL 400T TELEMETRY ECG MONITOR?

The FDA product code for ESCORT MODEL 400T TELEMETRY ECG MONITOR is DXH. This falls under the Hematology category.

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Other records listing Medical Data Electronics as applicant

K014294MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 K012336MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 K992413ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR K992411ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR K982104ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500

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Related Devices (Code: DXH)

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

Official Source

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