510(k) DEN180055
- Device
- CARPEDIEM System
- Applicant
- Bellco Srl (Now Part of Medtronic, Inc)
- 510(k) number
- DEN180055
- Product code
- QIR
- Decision
- Unknown (DENG)
- Decision date
- 2020-04-29
- Date received
- 2018-10-09
- Regulation
- 876.5861
- Classification name
- Pediatric Hemodialysis System
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Matteo Chiappini
- Address
- Via Camurana 1 Mirandola IT 41037 41037
FDA Registration Numbers#
- 3012914313
- 1000312731
- 9615942
- 3006849754
Source Documents#
510(k) summary PDF not indicated by FDA