FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
K Number: K133829
·
Decision Apr 22, 2014
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
116
Applicant Total
2
Review Days
126
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
- K Number
- K133829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5665
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vivonic GmbH
- Date Received
- December 17, 2013
- Decision Date
- April 22, 2014
- Product Code
- FIP
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FIP | Subsystem, Water Purification | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIP), ordered by most recent decision date.
AquaC UNO H
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIASAFEplusUS (F00013010)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AquaA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UPT Series Medical RO Water Treatment System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AquaBplus; AquaB LITE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AQUAbase nX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Vivonic GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K143617 | AquaC UNO H | Oct 19, 2015 | Substantially Equivalent |