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FDA 510(k)

ESCORT-LINK (MODEL E3200)

K-Number: K901591 · 1990-05-15

ApplicantMedical Data Electronics
Decision Date1990-05-15
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ESCORT-LINK (MODEL E3200) 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 1990-05-15 under 510(k) number K901591. 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-LINK (MODEL E3200)?

ESCORT-LINK (MODEL E3200) is a medical device that received FDA 510(k) clearance on 1990-05-15. The listed applicant is Medical Data Electronics. The 510(k) number is K901591.

When did ESCORT-LINK (MODEL E3200) receive FDA 510(k) clearance?

ESCORT-LINK (MODEL E3200) received FDA 510(k) clearance on 1990-05-15, under 510(k) number K901591.

Who is the listed applicant for ESCORT-LINK (MODEL E3200)?

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-LINK (MODEL E3200)?

The FDA product code for ESCORT-LINK (MODEL E3200) is DXH. This falls under the Hematology category.

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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: DXH)

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.

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

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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