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Found 1 results

510(k) Data Aggregation

K Number

Device Name

ACCUFUSER; ACCUFUSER PLUS

Manufacturer

HELPTECHNOLOGIES

Date Cleared

2001-02-15

(58 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

HELPTECHNOLOGIES

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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