PROTOCO2L INSUFFLATOR MODEL 6400— 510(k) K013219

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K013219 for PROTOCO2L INSUFFLATOR MODEL 6400, Substantially Equivalent on 2002-02-19. Applicant: E-Z-Em, Inc..

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code FCX
Advisory panel: Gastroenterology, Urology
Date received: 2001-09-26
Decision date: 2002-02-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Westbury, NY, US

Download summary PDF View on FDA.gov ↗

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