SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS— 510(k) K062362

Name: FDA 510(k) clearance K062362
Creator: U.S. Food and Drug Administration
Published: 2007-04-13

Substantially Equivalent

Sarmed Srl

FDA 510(k) clearance K062362 for SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS, Substantially Equivalent on 2007-04-13. Applicant: Sarmed Srl. Device class: 2.

Clearance details

Applicant: Sarmed Srl
Product code: Code KLA
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 2006-08-14
Decision date: 2007-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medolla, IT

Download summary PDF View on FDA.gov ↗

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