U.I. OCTOSON— 510(k) K802030

Clearance details

Applicant

Ausonics Pty , Ltd.

Product code

Code DXK

Device class

Class 2

Regulation

21 CFR 870.2330

Advisory panel

Cardiovascular

Date received

1980-08-21

Decision date

1980-10-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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