ARTOSCAN S— 510(k) K981358

Substantially Equivalent

Biosound Esaote, Inc.

FDA 510(k) clearance K981358 for ARTOSCAN S, Substantially Equivalent on 1998-07-13. Applicant: Biosound Esaote, Inc.. Device class: 2.

Clearance details

Applicant: Biosound Esaote, Inc.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1998-04-14
Decision date: 1998-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.