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510(k) Data Aggregation

K Number

Device Name

PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200

Manufacturer

AXELGAARD MFG. CO., LTD.

Date Cleared

2000-04-13

(83 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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