THE ULTRA SYSTEM SP— 510(k) K032813

Substantially Equivalent

Promedica, Inc.

FDA 510(k) clearance K032813 for THE ULTRA SYSTEM SP, Substantially Equivalent on 2004-02-13. Applicant: Promedica, Inc.. Device class: 2.

Clearance details

Applicant: Promedica, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2003-09-09
Decision date: 2004-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oldsmar, FL, US

Download summary PDF View on FDA.gov ↗

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