PHYSOFT AMS— 510(k) K130579

Substantially Equivalent

Physicians Software Systems, LLC

FDA 510(k) clearance K130579 for PHYSOFT AMS, Substantially Equivalent on 2013-12-19. Applicant: Physicians Software Systems, LLC. Device class: 2.

Clearance details

Applicant: Physicians Software Systems, LLC
Product code: Code MQS
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2013-03-05
Decision date: 2013-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lisle, IL, 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.