MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS— 510(k) K111007

Name: FDA 510(k) clearance K111007
Creator: U.S. Food and Drug Administration
Published: 2011-06-08

Substantially Equivalent

Midwest Reprocessing Center, LLC

FDA 510(k) clearance K111007 for MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS, Substantially Equivalent on 2011-06-08. Applicant: Midwest Reprocessing Center, LLC. Device class: 2.

Clearance details

Device name as filed: MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE
Applicant: Midwest Reprocessing Center, LLC
Product code: Code NMD
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2011-04-11
Decision date: 2011-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, AL, US

Download summary PDF View on FDA.gov ↗

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