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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

DORNIER COMPACT ALPHA LITHOTRIPTER

Manufacturer

DORNIER MEDTECH AMERICA, INC.

Date Cleared

2001-04-17

(209 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K011773,K040470,K103217,K142561

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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