DS-II DIGITAL SONOGRAPHY SYSTEM— 510(k) K864278

Name: FDA 510(k) clearance K864278
Creator: U.S. Food and Drug Administration
Published: 1987-06-10

Substantially Equivalent

Intl. Acoustics, Inc.

FDA 510(k) clearance K864278 for DS-II DIGITAL SONOGRAPHY SYSTEM, Substantially Equivalent on 1987-06-10. Applicant: Intl. Acoustics, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Acoustics, Inc.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 1986-10-30
Decision date: 1987-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palatine, IL, US

Download summary PDF View on FDA.gov ↗

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