SERIM HISENSE ULTRA 0.1, PART NUMBER 5167— 510(k) K080712

Name: FDA 510(k) clearance K080712
Creator: U.S. Food and Drug Administration
Published: 2008-05-06

Substantially Equivalent

Serim Research Corp.

FDA 510(k) clearance K080712 for SERIM HISENSE ULTRA 0.1, PART NUMBER 5167, Substantially Equivalent on 2008-05-06. Applicant: Serim Research Corp.. Device class: 2.

Clearance details

Applicant: Serim Research Corp.
Product code: Code MSY
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2008-03-13
Decision date: 2008-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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