CARPEDIEM System
FDA 510(k) clearance DEN180055 · decided 2020-04-29
Clearance details
- K-number
- DEN180055
- Device name
- CARPEDIEM System
- Applicant
- Bellco Srl (Now Part of Medtronic, Inc)
- Decision
- Unknown
- Date received
- 2018-10-09
- Decision date
- 2020-04-29
- Days to decision
- 568 days
- Clearance type
- Direct
- Product code
- QIR
- Device class
- 2
- Regulation number
- 876.5861
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mirandola, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.