RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER— 510(k) K883845

Name: FDA 510(k) clearance K883845
Creator: U.S. Food and Drug Administration
Published: 1989-02-03

Substantially Equivalent

Phoenix Imaging

FDA 510(k) clearance K883845 for RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER, Substantially Equivalent on 1989-02-03. Applicant: Phoenix Imaging. Device class: 2.

Clearance details

Applicant: Phoenix Imaging
Product code: Code DXK
Device class: Class 2
Regulation: 21 CFR 870.2330
Advisory panel: Cardiovascular
Date received: 1988-09-12
Decision date: 1989-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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