THE ULTRA— 510(k) K935755

Substantially Equivalent

Medical Device Systems, Inc.

FDA 510(k) clearance K935755 for THE ULTRA, Substantially Equivalent on 1995-05-05. Applicant: Medical Device Systems, Inc.. Device class: 2.

Clearance details

Applicant: Medical Device Systems, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1993-11-26
Decision date: 1995-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auburndale, 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.