THE ULTRA SYSTEM— 510(k) K032445

Substantially Equivalent

Promedica, Inc.

FDA 510(k) clearance K032445 for THE ULTRA SYSTEM, Substantially Equivalent on 2004-03-29. 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: 2003-08-08
Decision date: 2004-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oldsmar, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.