510(k) K030470
- Device
- NXSTAGE SYSTEM ONE
- Applicant
- NXSTAGE MEDICAL, INC.
- 510(k) number
- K030470
- Product code
- FII
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-07-07
- Date received
- 2003-02-12
- Regulation
- 876.5860
- Classification name
- System, Dialysate Delivery, Sealed
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- NORMA LEMAY
- Address
- 439 S. Union St. Suite 501 Lawrence MA US 01843 01843
Source Documents#
Other 510(k) Records For Product Code FII #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881270 | GAMBRO MULTIPURPOSE SYSTEM MPS-10 | Gambro, Inc. | 1988-08-24 |
| K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | Travenol Laboratories, S.A. | 1987-10-13 |
| K862716 | HEMOFILTRATION SYSTEM 10 | Gambro, Inc. | 1986-09-09 |
| K822386 | COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA | Hospal Medical Corp. | 1982-10-06 |
Legacy Summary#
summary
FDA Review#
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