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FDA 510(k)

ESCORT ECG MONITOR SIEMENS SIRECUST 466

K-Number: K854234 · 1986-01-21

ApplicantMedical Data Electronics
Decision Date1986-01-21
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ESCORT ECG MONITOR SIEMENS SIRECUST 466 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 1986-01-21 under 510(k) number K854234. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESCORT ECG MONITOR SIEMENS SIRECUST 466?

ESCORT ECG MONITOR SIEMENS SIRECUST 466 is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Medical Data Electronics. The 510(k) number is K854234.

When did ESCORT ECG MONITOR SIEMENS SIRECUST 466 receive FDA 510(k) clearance?

ESCORT ECG MONITOR SIEMENS SIRECUST 466 received FDA 510(k) clearance on 1986-01-21, under 510(k) number K854234.

Who is the listed applicant for ESCORT ECG MONITOR SIEMENS SIRECUST 466?

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 ECG MONITOR SIEMENS SIRECUST 466?

The FDA product code for ESCORT ECG MONITOR SIEMENS SIRECUST 466 is DPS.

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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

View all 27 devices →

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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