510(k) K141752
- Device
- NXSTAGE SYSTEM ONE
- Applicant
- NXSTAGE MEDICAL, INC.
- 510(k) number
- K141752
- Product code
- ODN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-12-19
- Date received
- 2014-06-30
- Regulation
- 876.5860
- Classification name
- Ultrafiltration-controlled Nocturnal Dialysate Delivery System
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY LOU STROUMBOS
- Address
- 350 Merrimack St. Lawrence MA US 01843 01843
Source Documents#
Other 510(k) Records For Product Code ODN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150472 | NxStage System One | Nxstage Medical, Inc. | 2015-06-04 |
Legacy Summary#
summary
FDA Review#
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