FDA 510(k)

MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR

K-Number: K970763 · 1997-07-14

Decision Date1997-07-14

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II 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 1997-07-14 under 510(k) number K970763. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR?

MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR is a medical device that received FDA 510(k) clearance on 1997-07-14. The listed applicant is Medical Data Electronics. The 510(k) number is K970763.

When did MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR receive FDA 510(k) clearance?

MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR received FDA 510(k) clearance on 1997-07-14, under 510(k) number K970763.

Who is the listed applicant for MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II 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 MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR?

The FDA product code for MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR is DQA.

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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: DQA)

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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.