Device Classification Name |
subsystem, water purification
|
510(k) Number |
K001811 |
Device Name |
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM |
Applicant |
NEU-ION, INC. |
7200 RUTHERFORD RD. |
SUITE 100 |
BALTIMORE,
MD
21244 -2704
|
|
Applicant Contact |
LEE A HEIKKINEN |
Correspondent |
NEU-ION, INC. |
7200 RUTHERFORD RD. |
SUITE 100 |
BALTIMORE,
MD
21244 -2704
|
|
Correspondent Contact |
LEE A HEIKKINEN |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 06/15/2000 |
Decision Date | 10/25/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|