Nexcore GI Insufflator— 510(k) K162332

Substantially Equivalent

Nexcore Technology, LLC

FDA 510(k) clearance K162332 for Nexcore GI Insufflator, Substantially Equivalent on 2016-09-29. Applicant: Nexcore Technology, LLC.

Clearance details

Applicant: Nexcore Technology, LLC
Product code: Code FCX
Advisory panel: Gastroenterology, Urology
Date received: 2016-08-19
Decision date: 2016-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winchester, MA, US

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