SW ULTRASOUND, MODELS 331, 311, 333— 510(k) K991613

Substantially Equivalent

Starbene

FDA 510(k) clearance K991613 for SW ULTRASOUND, MODELS 331, 311, 333, Substantially Equivalent on 2000-12-08. Applicant: Starbene. Device class: 2.

Clearance details

Applicant: Starbene
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 1999-05-10
Decision date: 2000-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cordoba, Pvcia. Cordoba, AR

Download summary PDF View on FDA.gov ↗

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