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510(k) Data Aggregation

K Number

Device Name

POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103

Manufacturer

MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

Date Cleared

2001-02-07

(22 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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