ACUSON S519 TRANSDUCER— 510(k) K861596

Name: FDA 510(k) clearance K861596
Creator: U.S. Food and Drug Administration
Published: 1986-07-30

Substantially Equivalent for Some Indications

Acuson Computed Sonography

FDA 510(k) clearance K861596 for ACUSON S519 TRANSDUCER, Substantially Equivalent for Some Indications on 1986-07-30. Applicant: Acuson Computed Sonography. Device class: 2.

Clearance details

Applicant: Acuson Computed Sonography
Product code: Code JOP
Device class: Class 2
Regulation: 21 CFR 870.2880
Advisory panel: Cardiovascular
Date received: 1986-04-29
Decision date: 1986-07-30
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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