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Fluid Process Systems Exchange Carbon and Deionization Tanks for Use in Hemodialysis

by Fluid Process Systems, Inc. 510(k)

Active United States

510(k) K991495

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991495 Date28 Aug 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FIP
Device Class
Class II
Regulation
21 CFR Part 876.5665
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent