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FDA 510(k)

ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION

K-Number: K914458 · 1991-12-09

ApplicantMedical Data Electronics
Decision Date1991-12-09
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION 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 1991-12-09 under 510(k) number K914458. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION?

ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION is a medical device that received FDA 510(k) clearance on 1991-12-09. The listed applicant is Medical Data Electronics. The 510(k) number is K914458.

When did ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION receive FDA 510(k) clearance?

ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION received FDA 510(k) clearance on 1991-12-09, under 510(k) number K914458.

Who is the listed applicant for ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION?

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 300A SERIES DEFIBRILLATOR/PACER OPTION?

The FDA product code for ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION is LDD.

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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: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, 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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