REDSENSE-ALARM UNIT AND SENSOR— 510(k) K103242

Name: FDA 510(k) clearance K103242
Creator: U.S. Food and Drug Administration
Published: 2011-02-10

Substantially Equivalent

Redsense Medical AB

FDA 510(k) clearance K103242 for REDSENSE-ALARM UNIT AND SENSOR, Substantially Equivalent on 2011-02-10. Applicant: Redsense Medical AB. Device class: 2.

Clearance details

Applicant: Redsense Medical AB
Product code: Code ODX
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2010-11-02
Decision date: 2011-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fridley, MN, 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.