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510(k) Data Aggregation

K Number

Device Name

SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801

Manufacturer

NIKO MEDICAL PRODUCTS

Date Cleared

2001-08-30

(265 days)

Product Code

DRX

Regulation Number

870.2360

Why did this record match?

Applicant Name (Manufacturer) :

NIKO MEDICAL PRODUCTS

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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