3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA— 510(k) K851616

Name: FDA 510(k) clearance K851616
Creator: U.S. Food and Drug Administration
Published: 1985-07-29

Substantially Equivalent

Ausonics Pty , Ltd.

FDA 510(k) clearance K851616 for 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA, Substantially Equivalent on 1985-07-29. Applicant: Ausonics Pty , Ltd.. Device class: 2.

Clearance details

Applicant: Ausonics Pty , Ltd.
Product code: Code JOP
Device class: Class 2
Regulation: 21 CFR 870.2880
Advisory panel: Cardiovascular
Date received: 1985-04-18
Decision date: 1985-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suffield, CT, US

Download summary PDF View on FDA.gov ↗

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