BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
FDA 510(k) clearance K111648 · decided 2011-11-03
Clearance details
- K-number
- K111648
- Device name
- BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
- Applicant
- Bracco Diagnostic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-13
- Decision date
- 2011-11-03
- Days to decision
- 143 days
- Clearance type
- Special
- Product code
- FCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.