ACEM— 510(k) K111013

Substantially Equivalent

Sandhill Scientific, Inc.

FDA 510(k) clearance K111013 for ACEM, Substantially Equivalent on 2011-12-19. Applicant: Sandhill Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Sandhill Scientific, Inc.
Product code: Code FFZ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2011-04-11
Decision date: 2011-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FFZ

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