K111648

Substantially Equivalent

BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR

Applicant: Bracco Diagnostic, Inc.
Product code: FCX
Advisory panel: Gastroenterology, Urology
Date received: 2011-06-13
Decision date: 2011-11-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.