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FDA 510(k)

ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR

K-Number: K992411 · 1999-08-18

ApplicantMedical Data Electronics
Decision Date1999-08-18
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ESCORT II+ 400 SERIES (ESCORT PRISM) 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 1999-08-18 under 510(k) number K992411. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR?

ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR is a medical device that received FDA 510(k) clearance on 1999-08-18. The listed applicant is Medical Data Electronics. The 510(k) number is K992411.

When did ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR receive FDA 510(k) clearance?

ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR received FDA 510(k) clearance on 1999-08-18, under 510(k) number K992411.

Who is the listed applicant for ESCORT II+ 400 SERIES (ESCORT PRISM) 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 II+ 400 SERIES (ESCORT PRISM) MONITOR?

The FDA product code for ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR is DRT.

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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 MONITORK982104ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500K970763MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR

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Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, 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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