BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR— 510(k) K132192
Substantially EquivalentBracco Diagnostic, Inc.
FDA 510(k) clearance K132192 for BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR, Substantially Equivalent on 2014-02-14. Applicant: Bracco Diagnostic, Inc.. Device class: 2.
Clearance details
- Applicant
- Bracco Diagnostic, Inc.
- Product code
- Code FCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monroe Township, NJ, US
Recent devices under product code FCX
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