STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000— 510(k) K100852

Name: FDA 510(k) clearance K100852
Creator: U.S. Food and Drug Administration
Published: 2010-05-06

Substantially Equivalent

Stryker Communications

FDA 510(k) clearance K100852 for STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000, Substantially Equivalent on 2010-05-06. Applicant: Stryker Communications. Device class: 2.

Clearance details

Applicant: Stryker Communications
Product code: Code OCS
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2010-03-26
Decision date: 2010-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flower Mound, TX, US

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