750 SD ULTRASOUND SCANNER(MODIFICATION)— 510(k) K851901

Name: FDA 510(k) clearance K851901
Creator: U.S. Food and Drug Administration
Published: 1985-10-23

Substantially Equivalent

Ultrasonix, Inc.

FDA 510(k) clearance K851901 for 750 SD ULTRASOUND SCANNER(MODIFICATION), Substantially Equivalent on 1985-10-23. Applicant: Ultrasonix, Inc.. Device class: 2.

Clearance details

Applicant: Ultrasonix, Inc.
Product code: Code DXK
Device class: Class 2
Regulation: 21 CFR 870.2330
Advisory panel: Cardiovascular
Date received: 1985-04-30
Decision date: 1985-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Yonkers, NY, US

Download summary PDF View on FDA.gov ↗

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